The long road to approval for Mannkind's Afrezza inhaled insulin got a little longer March 15, as the FDA asked for more information to support its review of the drug. Afrezza is a powdered insulin for helping adult patients with type 1 and type 2 diabetes mellitus control high blood glucose, also known as hyperglycemia, which is a major cause of diabetes-related complications. An FDA decision on the drug was initially expected by January 16. Now the final decision date has been pushed into an indeterminate future.

 

The FDA is looking for information and currently available clinical data that support the clinical utility of Afrezza, says Mannkind. It also wants information about how Mannkind's first inhaler, the MedTone, compares to the earlier version of Afrezza inhaler used in pivotal clinical trials.

 

Mannkind was quick to point out that the letter from the FDA expressed no safety concerns or need for further pre-marketing clinical studies of Afrezza. The company also says it’s still confident that it will be still be able to find a partner for marketing Afrezza for a launch by 2011.

 

“We will work closely with the FDA to answer quickly the agency’s questions and satisfy the requirements,” says Alfred Mann, Mannkind's CEO.

 

Some investors and analysts took a dim view of the news, knocking the company’s shares down 5 percent between March 15's market close and the end of trading March 18. But Rodman & Renshaw analyst Simos Simeonidis was largely positive, suggesting that things could have been worse.

 

“Obviously, a straight approval would have been the ideal scenario,” he said, but the news “means that Afrezza approval is still very much alive, and with significant overhangs removed,” Simeonidis told clients.

 

Concerns about whether the FDA may require Afrezza-takers to submit to periodic lung function tests persist. Pfizer's failed inhaled insulin product, Exubera, fell victim in part to a scheme of FDA-mandated tests, called a risk evaluation and mitigation strategy, which monitored people taking Exubera for signs of lung cancer. Worries that Afrezza might face the same burdensome requirement have yet to be dispersed.

 

At least Mannkind has good company. Lilly and its partner Amylin Pharmaceuticals also received a complete response letter from the FDA March 15, denying approval of Byetta LAR, a long-acting version of the type 2 diabetes drug Byetta. Wall Street took that as good news, since the agency didn't ask for any new clinical data or analysis.