Drug makers get dose of bad regulatory news

Share this article:
FDA medical reviewers voted unanimously not to approve Abbott Laboratories' Xinlay (atrasentan), which the company sought to market for treating men with metastatic hormone-refractory prostate cancer.
Members of the Oncologic Drugs Advisory Committee said Abbott's NDA failed to prove that the drug delayed disease progression in the treatment group. The agency has until October to decide whether to approve it.
"Abbott respects the committee's vote on Xinlay today; however, we continue to believe that Xinlay represents an important option for patients with advanced prostate cancer who currently have limited options," Dr. Eugene Sun, Abbott's vice president, global pharmaceutical clinical development, said in a statement.
Despite the panel's efficacy questions, Sun said Abbott will continue studying the drug, saying he was encouraged by committee member statements regarding its biological activity. A Phase III trial in hormone-refractory prostate cancer patients without metastasis is ongoing and is expected to be completed next year.
In other news, Pfizer has received a non-approvable letter from the FDA regarding Oporia (lasofoxifene), a selective estrogen receptor modulator for the prevention of osteoporosis.
In a statement, Pfizer said it will review its submission with the FDA and consider various courses of action but did not disclose the reason for the agency's decision.
Pfizer also submitted Oporia for treating vaginal atrophy in December, but the agency has not responded to that application, a spokeswoman told MM&M.
Share this article:

Email Newsletters

More in News

Lilly's cancer drug ramu granted gastric indication

Lilly's cancer drug ramu granted gastric indication

Ramucirumab received FDA approval today in advanced gastric cancer, a nod that could translate into $600 million in peak sales.

GSK, Novartis, Lilly play musical chairs

GSK, Novartis, Lilly play musical chairs

The three drugmakers rearranged part of the pharma universe Tuesday with a string of pipeline-altering deals.

Valeant bids $47B for Allergan

Valeant bids $47B for Allergan

The deal would bring Allergan's Botox and Juvederm under the same roof as Restylane.