Blockbusters face a final decision from FDA

[industry_news]

The FDA is facing a pair of big PDUFA dates, and the agency's conclusions will make or break two would-be blockbusters.
The analysts are closely focused on the fate of Xarelto, an anticoagulant that Bayer is advancing with Johnson & Johnson. If the FDA agrees with its expert panel, which voted 15 to 2 for an approval, the agency would usher in the first new oral blood thinner since warfarin was released a half century ago. The regulators would also be giving a green light to a therapy likely to bring in close to $3 billion a year in sales.
Analysts, though, say that concerns about Xarelto's side effects could prompt the agency to do a risk evaluation and mitigation study, delaying the final approval.
The other drug in the regulatory spotlight next week will be the leukemia drug Arzerra, advanced by GlaxoSmithKline and Genmab, which is an odds-on favorite for approval. Arzerra would compete with the megablockbuster Rituxan and help CEO Andrew Witty establish Glaxo as more of a force in the cancer field.
- read the article from Reuters
Related Articles:
Bayer shares soar as FDA panel backs Xarelto
Bayer shares sink on FDA staff's Xarelto review
J&J, Bayer report Phase II Xarelto data
Arzerra (ofatumumab) granted priority review
GSK, Genmab report strong ofatumumab data


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