Schering's Antipsychotic Saphris Should Have Easy Advisory Committee Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Label for asenapine could be highly favorable on weight and adverse event issues given FDA's enthusiasm.
|
FDA appears to be looking to its Psychopharmacologic Drugs Advisory Committee for the final nudge toward approving Schering-Plough's atypical antipsychotic Saphris (asenapine) for schizophrenia and bipolar disorder in adults. In briefing materials released prior to the July 30 meeting, the agency states that it hasn't yet made a final conclusion on the application, but makes it clear that it doesn't have any problems with it. "We generally are in agreement that the sponsor has provided adequate support to suggest effectiveness for asenapine for the claimed indications," FDA Director Division of Psychiatry Products Tom Laughren writes in briefing documents. "In addition, we view the safety profile for this product in the populations studied to be qualitatively similar to that observed for other atypical antipsychotic drugs, and to be acceptable. Chemistry, toxicology, and biopharmaceutics issues for the application have also been resolved, and we are currently discussing proposed labeling for the product with the sponsor." Breaking with standard procedure, FDA won't even be making a presentation at the meeting, "since we are in essential agreement with the data to be presented by the sponsor," the briefing documents state. Nevertheless, the panel will be asked to weigh in on the safety and effectiveness of asenapine for both indications. Saphris appears worth the wait If approved, asenapine would join an already crowded antipsychotic class. But the limitations of currently available treatment options show FDA more amenable to approving still further treatments than once thought (Also see "Schering Plough’s Antipsychotic Saphris To Face FDA Panel Review In July" - Pink Sheet, 8 Jun, 2009.). All atypical antipsychotics are effective only in a subset of patients that can't be predicted prior to treatment, and come with a host of safety and tolerability issues, including somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms and tardive dyskinesia. Schering-Plough writes in briefing materials that in terms of those common safety problems, asenapine showed limited effects on weight, metabolic laboratory parameters, orthostasis and prolactin levels, and that the drug has a low propensity to induce EPS, has no increased risk of suicidality and no clinically relevant effects on the QT interval or liver parameters. The clinical development program included 2,251 subjects in Phase II/III studies. Of those, 252 were exposed for at least 26 weeks and 225 for at least a year. "As such, asenapine is a promising alternative to existing approved therapies," the firm writes. The agency issued a "complete response" letter for the application earlier this year requesting supplemental data (Also see "Schering-Plough's Saphris Hits FDA Roadblock With "Complete Response"" - Pink Sheet, 14 Jan, 2009.). The company turned the letter around in just over a month ("Pharmaceutical Approvals Monthly" Feb. 25, 2009, p. 52). Asenapine is formulated as a fast-dissolving tablet for sublingual administration. -Jamie Hammon ([email protected]) |