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:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...