UPDATED & CORRECTED:
06.10.09 @ 6:30 AM EDT
Credit Salmon: Salmon found the Federal Register item in question — July 30, 2009 is the planned FDA Advisory Committee Meeting at which Asenapine will be considered for approval. I now humbly bow before Salmon’s superior prowess — that of parsing FDA back-water publications — more seriously, I am indebted. Corrections now noted, below, throughout.
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Some online desk called “The Consumer Memo“, inside the Kansas City Star’s constellation(!) of web-columns is running the below item, tonight — and at least as to Schering-Plough’s Saphris (asenapine) — it appears to be a case of “mistaken (chemical compound, and company) identities“ my inability to read the Federal Register, online:
. . . .Cancer drug review
Johnson & Johnson’s experimental cancer treatments and Schering-Plough Corp.’s new antipsychotic drug will be reviewed next month by outside advisers to the U.S. Food and Drug Administration. The FDA’s Oncologic Drugs Advisory Committee will meet July 15 to review J&J’s trabectedin infusion combined with Doxil for relapsed ovarian cancer and Doxil combined with docetaxel for breast cancer, according to a notice posted today on the agency’s Web site. . . .
Presumably, he means to refer to Saphris (Asenapine). I can verify — and thus will immdediately accept — that the ODAC is meeting July 15 on J&J’s above-candidate. However, the only notices most current notice for an upcoming meeting on antipsychotics is for potential pediatric indications (as Salmon let us know, almost a full week ago!), here, and here. Among them is Lilly’s Zyprexa; Astra-Zeneca’s Seroquel and Pfizer’s Geodon. But no asenapine, at the-below meeting.
Nope, no Schering-Plough’s upcoming meeting agenda item exists, is scheduled for July 30, 2009, via the online Federal Register. The below, as I said, however, is on the agenda for June 9-10, 2009:
Agenda
The committee will discuss safety and efficacy issues for the following new drug applications (NDA): 1) NDA 20-639/S-045 and S-046: Seroquel (quetiapine), AstraZeneca Pharmaceuticals LP, for (a) the acute treatment of schizophrenia in adolescents (13-17 years of age), and (b) the acute treatment of bipolar mania in children (10-12 years of age) and adolescents (13-17 years of age); 2) NDA 20-825/S-032: Geodon (ziprasidone), Pfizer Inc., for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages 10-17 years; and 3) NDA 20-592/S-040 and S-041: Zyprexa (olanzapine), Eli Lilly and Company, for (a) the acute treatment of manic or mixed episodes associated with bipolar I disorder, and (b) the acute treatment of schizophrenia in adolescents. The committee will be asked to vote on whether or not these products have been shown to be effective and acceptably safe for these pediatric indications. . . .
So, I think I Steve Rosen, the author of this “Consumer Memo” column, just simply got his my wires crossed.
