FDA panel backs Schering-Plough antipsychotic

Schering-Plough took another big step in its quest to gain marketing approval for the antipsychotic blockbuster asenapine, winning the backing of an expert panel in a lopsided vote.

The panel voted 9 to 1--with two abstentions--that the drug's benefits outweighed its risks in treating schizophrenia. And there was a unanimous vote that asenapine should be recommended as a therapy for manic or mixed episodes of bipolar disorder.

If the agency goes ahead and approves the drug, which would be marketed as Saphris, the therapy would compete with Eli Lilly's Zyprexa and AstraZeneca's Seroquel, notes Bloomberg. Formulated to dissolve under the tongue, the data on asenapine suggests that it can be used for patients who can't swallow pills or for a group that experience serious side effects, such as weight gain. And the analysts say that safety profile could help win over a big chunk of the market.

"We believe that the opportunity for Saphris is under-appreciated, as we think an antipsychotic with little to no weight gain and no cardiovascular safety issues is a lay-up blockbuster," wrote analyst Jon LeCroy. "We are modeling 2013 sales of $650 million."

- read the story from Bloomberg

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