News on Wellness

‘Afrezza’ the Inhaled Insulin Drug Approved By US Advisory Panel

Afrezza

Afrezza, the inhaled insulin created by Mannkind Corporation has been approved by the US advisory panel as per the company statement released yesterday. The advisers voted 13 to 1 and 14 to 1 to approve this drug for type I and type II diabetes. However, the report also stated that the staff of FDA had raised the concern about the missing data on a study conducted on patients suffering with type I diabetes. This report also showed that they were concerned about ill effects of this drug on the lung function.

Afrezza

New York Times reported that after extensive research and clinical trials for about 8 years, it has been approved after being rejected twice by the FDA. Alfred Mann, the chairman, CEO and founder of the company released a statement saying that the company is delighted with the approval and recommendation of the drug Afrezza. He also added that diabetes being one of the major health issues in the United States; they hope Afrezza will bring benefits to diabetes patients.

However, reports say that despite of the recommendation by the panel members, there are still some reservations regarding the potential risks. The approval was given the as the benefits outweighed the concerns when compared to the insulin injections. It was also reported that they have recommended addressing the issues in the label of the medicine. Further, the staffs also suggested to conduct 2 post-sales studies to see Afrezza causes lung cancer if approved for sales. The approval to sell the drug will be given by FDA by April 15.

New York Times reported that the share price of the company declined about 17% owing to the meeting in the last 4 days, as the investors were concerned. Bloomberg analyst’s report that, approval of Afrezza is likely to boost sales and it is expected to generate about $534 million by 2018.

 

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