Monday, September 15, 2014

Additional FDA Filing Date Delays, For Merck's Odanacatib -- As Safety Signals Seem To Appear

Once again, the next gen Merck osteoporosis candidate has been run aground, and run aground -- hard. Now a mid 2015 FDA filing may be a stretch -- and peak sales may come in under $300 million a year. Ouch.

here is our February 2013 background piece on the program.

John Carroll is chief among the smart folks over at FierceBiotech -- and he has a nice, pithy analysis of the data, and consequent additional delays up:

. . . .[T]here was also evidence of a troubling side effect profile that could well damage Merck's prospects. There was a slight increase in the risk of atrial fibrillation as well as more strokes in the odanacatib crowd. A total of 109 patients (1.4%) had a stroke in the drug arm, compared to 89 (1.1%) in the placebo arm.

Cardiovascular side effects are going to attract careful regulatory attention. More morphea-like skin lesions and atypical femoral shaft fractures were also reported for 5 patients in the odanacatib group with none in the placebo group. And Merck--which had been expected to file before the end of this year---says it will now delay its FDA submission until next year after it gathers more data.. . .

We will keep the readership posted.

Tough breaks -- rather literally.

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