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Monday, 06/30/2014 11:42:57 AM

Monday, June 30, 2014 11:42:57 AM

Post# of 32013
Headline in AMA daily executive summary:

Leading the News
FDA approves inhalable diabetes medication.
News that the FDA approved Friday an inhalable diabetes medication, Afrezza. was covered by major US newspapers, news agencies and by at least one television network. Several media outlets highlighted the challenges faced by the product’s manufacturer, MannKind Corp., and how the medication was approved in the shadow of failures of other companies to develop such a product. NBC Nightly News (6/27, story 7, 0:35, Williams) reported in its broadcast the “news will be of big interest for millions of Americans living with diabetes.”
According to the New York Times (6/28, Pollack, Subscription Publication) the approval marks a “milestone in a long and expensive journey for its developer,” MannKind. The piece also highlighted the company’s challenges, noting the firm “has not signed up a larger pharmaceutical company to help market Afrezza, even though it has said for years that it was in discussions with potential partners.”
The Wall Street Journal (6/28, Beckerman, Silverman, Subscription Publication) reported the medication has drawn the spotlight on Wall Street because of its potential to capture market share from treatments that require regular injections.
The Los Angeles Times (6/28, Pfeifer, Hennigan) highlighted that the medication is for people with Type 1 and Type 2 diabetes, noting the FDA has added a “warning that the product shouldn’t be used by those with diabetes who also have asthma or a serious lung disease.” The paper also provided details of the medication, noting “the drug is a powder that is administered through a device about the size of an asthma inhaler.” The Times pointed out that it “would be most often used to help control blood-sugar levels at mealtime, a quick puff replacing a needle injection before a meal.”
According to the AP (6/30), the FDA has cautioned that Afrezza “is not a substitute for long-acting insulin and is a new option for controlling insulin levels during meals.” According to the piece, “several other companies have failed to make inhaled insulin work commercially,” noting the example of Pfizer Inc.’s discontinued inhaled insulin Exubera in 2007 and Eli Lilly & Co.’s 2008 ending of its development program, “citing regulatory uncertainty.”
The news was also covered by Bloomberg News (6/30, Chen), the Tennessean (6/27), the San Fernando Valley (CA) Business Journal (6/27), HealthDay (6/30), MedPage Today (6/30) and Medscape (6/30).
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