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Inhaled Insulin Associated with Excess of Lung Cancer Cases

Posted: Friday, April 18, 2008

The FDA has warned that more cases of lung cancers have been reported in patients treated with the inhaled insulin Exubera than in controls in clinical trials. So with this new information it looks like the end of research on inhaled insulins. 

The warning is another blow to the star-crossed Exubera, which was hailed as the only new method of delivering insulin in 80 years when it was approved in 2006 However, less than two years later, Pfizer, the drug's maker, said it was phasing the drug out because patients and doctors had been slow to accept it.

Some patients continue to use Exubera, especially those on Pfizer's extended transition program, initiated when the company pulled the plug on the medication.

In the clinical trials, the FDA said, there have been six newly diagnosed cases of primary lung cancers among Exubera patients and only one among controls treated with comparator medications.  Also, there has been a single post-marketing report of lung cancer in a patient using the drug.

The FDA said there have been "too few cases to determine whether the emergence of these events is related to Exubera" and the agency pointed out that all patients diagnosed with lung cancer had a history of cigarette smoking.

The information about the cancers will be added to the drug's labeling, Pfizer said in a Dear Healthcare Professional letter. The company added the drug remains "safe and effective" in the treatment of types 1 and 2 diabetes.

But because availability of the drug is limited, the company said, doctors "should seek alternative treatment options to maintain patients' glycemic control."

In its approval statement, the FDA noted that the safety and efficacy of Exubera had been studied in approximately 2,500 adult patients with type 1 and type 2 diabetes.

Also it was just announced that Nektar Therapeutics will no longer be looking for a partner to replace Pfizer for its inhaled insulin, Exubera.  And with Novo and Lilly both discontinuing their research into an inhaled insulin, that leaves just one company left, which is Mannkind to work on their brand of inhaled insulin.  But even that company will have a hard time now, to find a partner and their stock falling to its lowest point of $2.25 from its high of 15 dollars last March.

Source: Diabetes In Control

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