MANNKIND - 2013 endlich zum Überflieger?
2.1§Afrezza (pulmonary insulin), MannKind Corp
MannKind confirms lower rates of hypoglycaemia with Afrezza vs NovoRapid®
The two phase 3 trials AFFINITY-1 and AFFINITY-2, in T1DM and T2DM patients, respectively, will be presented with additional data on hypoglycaemia and baseline characteristics. In T1DM, hypoglycaemic event rates were lower with Afrezza vs NovoRapid® at 24 weeks at all HbA1c levels (≤6.5 %, ≤7%, and ≤8%). (ADA2014, 127-OR, Bode, Saturday 14 June, 16.00-16.15, and 128-OR, Rosenstock, Saturday 14 June, 16.15-16.30, Oral session: Prandial In*sulin Therapy, S-102)
Comment: MannKind has previously reported top-line results from the two phase 3 trials. On 1 April 2014, an FDA advisory committee nearly unanimously voted in favour of approval of Afrezza. MannKind resubmitted Afrezza to the FDA in October 2013 following two complete response letters, the latter requesting these additional phase 3 trials. After the AdComm meeting, the FDA postponed the PDUFA date from 15 April to 15 July 2014.
Gratulation!
Bin ja nicht dabei.........vielleicht war ich da zu kritisch.
wie siehst Du als Profi diese Ergebnisse, für mich sensationell, deutlich weniger hypoclycemia Events als die Konkurrenz, und deutlich schneller im Körper (15 Minuten) und deutlich schneller raus, Ultra rapid Action halt!
Gerade bei einer prandialen Therapie ist eine geringe Hyporate sehr wichtig und "schnell rein, schnell raus" ist auch eine tolle Eigenschaft.
Interessant wird die Frage nach dem Preis und ob die Diabetologen einen praktischen Vorteil sehen.
Für Deutschland habe ich da meine Bedenken. Wenn man sich überlegt, wie hoch noch immer die Rate an verordnetem Humaninsulin ist, könnte man graue Haare bekommen.
Der Vorteil der analogen Insuline liegt auf der Hand, wird aber konsequent, von einem erheblichen Teil der Ärzte, NICHT genutzt.
Da muss man sich schon die Frage stellen, warum das so ist.
Aber zum Glück ist der Weltmarkt ein anderer und wird nicht von den deutschen Diabetologen bestimmt.
Das Galvus und Eucreas aus dem Handel genommen werden, betrifft aber nur Deutschland!
Bin mal gespannt, wohin die AMNOG Geschichte uns noch führt, ist ja nicht das erste Unternehmen, welches ein Präparat in D nicht mehr anbietet.
Er hat davon berichtet, dass es "da ja bald ein inhalatives Insulin" geben wird.
Die Gelegenheit wollte ich nutzen und habe ihn natürlich danach gefragt, wie die Resonanz der Fachkollegen ausgefallen sei.
Nun, die Diabetologen (als Anwender) sehen Afrezza prinzipiell positiv.
Aber er hat auch ganz deutlich von Bedenken der Fachkreise berichtet, was die Anwendung im Alltag angeht.
Zunächst sei es so, dass die Patienten die kurzwirksames Insulin bekommen, auch praktisch immer ein Basalinsulin benötigen, was noch immer gespritzt werden muss. Zu bedenken sei hier, dass im Alltag der Umgang mit unterschiedlichen Systemen zur Verabreichung oft nicht unproblematisch sei.
Was auch ein Thema gewichtiges Thema gewesen sei, ist die Frage, wo bleibt das nicht resorbierte Insulin? Da nach Applikation ein erheblicher Anteil nicht resorbiert wird, sei diese Frage intensiv diskutiert worden. Zusätzlich kämen deutliche Wirkverluste, schon bei relativ schwachen Atemwegsinfekten hinzu und bei COPD oder chronischer Bronchitis ist es eh indiskutabel.
Noch ein Diskussionspunkt war wohl auch die Frage, ob Insulin generell über die Lunge verabreicht werden sollte.
Er betonte, dass deutlich dargelegt wurde, dass es keinerlei negative Daten gebe. Aber die Ärzte hätten trotzdem Bedenken geäussert, was die Wirkung auf das Lungengewebe in der Langzeitbehandlung betrifft, da Insulin schließlich ein Wachstumshormon sei.
Bei dem Thema ging es nicht um Karzinome, es wurde nur darauf hingewiesen, dass es doch auch deutliche Verwachsungen bei vielen Patienten im Fettgewebe gebe.
Da ich nicht persönlich bei dem Gespräch auf dem Kongress anwesend war, muss ich diese Aussagen als wahrheitsgetreu annehmen.
Mal schau´n, wenn es dann wirklich mal auf den Markt kommt, wie dann die Akzeptanz sein wird.
Gruß
Aber es ist das erste ultra-rapid-Action Insulin mit deuchtlich weniger hypoclycemia Events, daß wird die Diabetiker zum einfachen indiskreten Gebrauch animieren!
Wollte Euch einfach nur mitteilen, mit welchen Gedanken die Doc´s so beschäftigen.
War rein informativ, ohne Wertung.
Spannend bleibt´s allemal!!!
http://finance.yahoo.com/news/...halable-diabetes-drug-194436610.html
MannKind Wins U.S. FDA Approval for Inhaled Insulin
By Caroline Chen Jun 27, 2014 8:58 PM GMT+0100
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JulSepNov2014MarMay4.006.008.0010.00* Price chart for MANNKIND CORP. Click flags for important stories. MNKD:US10.00-0.58 -5.48%
MannKind Corp. (MNKD) won U.S. approval to sell its inhaled insulin, culminating an almost decade-long effort, though regulators warned the product shouldn’t be used by those with asthma or a serious lung disease.
The Food and Drug Administration said today it cleared MannKind’s Afrezza for Type 1 and Type 2 diabetes. The drug labeling will warn that spasms in the airways of the lung have been seen in patients with asthma and chronic obstructive pulmonary disease and will advise against smokers using the medicine, the agency said in a statement.
MannKind has spent almost eight years seeking approval of the diabetes therapy since starting late-stage clinical trials. The Valencia, California-based company’s share price has bounced from a high of $21.70 to a low of $1.60 as Pfizer Inc. pulled the only inhaled insulin from the market and the FDA twice rejected MannKind’s therapy, most recently in 2011, after the company switched inhalers during the review process.
Shares of MannKind fell 16 percent to $8.91 at 3:47 p.m. New York time.
To contact the reporter on this story: Caroline Chen in New York at cchen509@bloomberg.net
To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Andrew Pollack, Drew Armstrong
MannKind Corporation Announces FDA Approval of AFREZZA(R); A Novel, Rapid-Acting Inhaled Insulin for the Treatment of Diabetes
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VALENCIA, Calif., June 27, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD) today announced that the U.S. Food & Drug Administration (FDA) has approved AFREZZA(R) (insulin human) Inhalation Powder to improve glycemic control in adult patients with diabetes mellitus.
"Approval of AFREZZA is an important milestone for MannKind, as today's FDA action validates the years of clinical research and commitment that powered the development of this unique therapy," said Alfred Mann, Chief Executive Officer, MannKind Corporation. "We are excited for patients, as we believe that AFREZZA's distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated. We thank the more than 6,500 adult patients and healthy volunteers who participated in the AFREZZA clinical program."
Currently, diabetes mellitus affects 29.1 million people in the United States, according to the Centers for Disease Control and Prevention. Diabetes mellitus is characterized by the body's inability to regulate levels of blood glucose properly. Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels, but in people with diabetes mellitus insufficient levels of insulin are produced or the body fails to respond adequately to the insulin it produces. In patients with diabetes, current injected insulins are absorbed into the bloodstream slower than the body's own insulin would be released if the pancreas was healthy.
AFREZZA(R) (uh-FREZZ-uh) is a novel, rapid-acting inhaled insulin therapy indicated to improve glycemic control in adult patients with diabetes mellitus. The product consists of AFREZZA Inhalation Powder delivered using a small, discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA dissolves rapidly upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration, and decline to baseline by approximately 180 minutes.
"The FDA approval of AFREZZA provides healthcare professionals with an important new safe and effective treatment option for patients with diabetes," said Janet McGill, M.D., Professor of Medicine at Washington University School of Medicine. "We have seen in clinical studies that the combination of rapid action, injection-free delivery and ease of use makes AFREZZA a welcome alternative for many patients who require insulin."
LIMITATIONS OF USE: AFREZZA must be used in combination with a long-acting insulin in patients with type 1 diabetes mellitus. AFREZZA is not recommended for the treatment of diabetic ketoacidosis and is not recommended for patients who smoke.
Full US Prescribing Information, including BOXED WARNING, Medication Guide and Instructions for Use will soon be available at www.afrezza.com. Prior to the label being posted online, a copy of the label may be requested from the MannKind Media contacts listed at the end of this document.
AFREZZA has been approved with a Risk Evaluation and Mitigation Strategy (REMS) required by the FDA to ensure that the benefits of AFREZZA outweigh the potential risk of acute bronchospasm in patients with chronic lung disease.
Important Safety Information about AFREZZA (insulin human Inhalation Powder)
The following information is taken from the highlights section of the US Prescribing Information. Please see full Prescribing Information including boxed warning.
BOXED WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating AFREZZA, perform a detailed medical history, physical examination and spirometry (FEV1) to identify potential lung disease in all patients.
CONTRAINDICATIONS
AFREZZA is contraindicated during episodes of hypoglycemia, in patients with chronic lung disease such as asthma or chronic obstructive pulmonary disease (COPD), or in patients with a hypersensitivity to regular human insulin or any of the AFREZZA excipients.
WARNINGS AND PRECAUTIONS
Acute Bronchospasm: Acute bronchospasm has been observed in patients with asthma and COPD. Before initiating, perform spirometry (FEV1) in all patients. Do not use in patients with chronic lung disease.
Change in Insulin Regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring.
Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to; insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness.
Decline in Pulmonary Function: Assess pulmonary function (e.g., spirometry) before initiating, after 6 months of therapy, and annually, even in the absence of pulmonary symptoms.
Lung Cancer: AFREZZA should not be used in patients with active lung cancer. In patients with a history of lung cancer or at risk for lung cancer, the benefit of AFREZZA use should outweigh this potential risk.
Diabetic Ketoacidosis: More patients using AFREZZA experienced diabetic ketoacidosis in clinical trials. In patients at risk for DKA, monitor and change to alternate route of insulin delivery, if indicated.
Hypersensitivity Reactions: May be life-threatening. Discontinue AFREZZA, monitor and treat if indicated.
Hypokalemia: May be life-threatening. Monitor Potassium levels in patients at risk of hypokalemia and treat if indicated.
Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.
ADVERSE REACTIONS
The most common adverse reactions associated with AFREZZA (2% or greater incidence) are hypoglycemia, cough, and throat pain or irritation.
About MannKind Corporation
MannKind Corporation (MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes", "anticipates", "plans", "expects", "intend", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks detailed in MannKind's filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2013 and periodic reports on Form 10-Q and Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
MannKind wins long sought FDA approval for insulin inhaler
Alfred Mann
Los Angeles biotech entrepreneur Alfred Mann founded Mannkind, maker of Afrezza. (Kirk McKoy / Los Angeles Times)
By W.J. Hennigan contact the reporter
This article is related to: Pharmaceutical Industry, MannKind Corporation, Diabetes, Food and Drug Administration
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Los Angeles billionaire-inventor Alfred Mann's almost decade-long quest to develop inhalable form of insulin.
June 27, 2014, 2:18 PM
Los Angeles billionaire-inventor Alfred Mann's almost decade-long quest to develop an inhalable form of insulin for diabetics won approval Friday from U.S. regulators..
His company, MannKind Corp. of Valencia, got the OK on Friday to sell the drug called Afrezza, although regulators warned the product shouldn’t be used by those diabetics with asthma or a serious lung disease.
New diabetes statistics show rising tide of disease
New diabetes statistics show rising tide of disease
by Melissa Healy
The Food and Drug Administration said it cleared Afrezza for Type 1 and Type 2 diabetes. The drug is a powder that is inhaled. It would be most often used to help control blood-sugar levels at mealtime, a quick puff replacing an injection before a meal.
The drug labeling will warn that spasms in the airways of the lung have been seen in patients with asthma and chronic obstructive pulmonary disease and will advise against smokers using the medicine, the agency said in a statement.
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It’s been a long, expensive journey to get Afrezza to this stage. MannKind has spent about $1.8 billion developing the drug, with about $975 million of that coming from Mann’s personal wealth. It took almost eight years seeking approval of the diabetes therapy since starting late-stage clinical trials.
Mannkind's share price has ranged from a high of $21.70 to a low of $1.60 as Pfizer Inc. pulled the only inhaled insulin from the market and the FDA twice rejected MannKind’s therapy, most recently in 2011, after the company switched inhalers during the review process.
Follow @wjhenn for L.A. business news.
Warum ist der Kurs vorher so abgeschmiert? Hat da jemand ne Erklärung für?
Es ging darum möglich viele SL abzufischen um doch noch an shares zu kommen, da diese natürlich rar gesäht sind bei einem Approval, ganz schöne Schweinere das sowas möglich ist, denn es ist reine Manipulation!!!:-(