Vanda Receives FDA Not Approvable Letter for Schizophrenia Drug
Posted on: Wednesday, 30 July 2008, 09:01 CDT
Vanda Pharmaceuticals has received a not approvable letter from the FDA in response to its new drug application for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.
The FDA stated that Vanda had demonstrated the effectiveness of iloperidone at 24mg/day in the 3101 study for which the company reported results in December 2006, and that the efficacy was similar to the active comparator, ziprasidone (Geodon, Pfizer).
In addition, the FDA also stated that iloperidone was superior to placebo in patients with schizophrenia at doses of 12-16mg/day and 20-24mg/day in a prior study.
However, the FDA expressed concern about the efficacy of iloperidone in patients with schizophrenia relative to the active comparator, risperidone (Risperdal, Johnson & Johnson), used in prior studies.
The FDA indicated that it would require an additional trial comparing iloperidone to placebo and including an active comparator such as olanzapine (Zyprexa, Eli Lilly & Company) or risperidone in patients with schizophrenia to demonstrate the compound's efficacy further. The FDA also stated that it would require Vanda to obtain additional safety data for patients at a dose range of 20 to 24mg/day.
Mihael Polymeropoulos, Vanda's president and CEO, said: "We are disappointed by this response, but will meet with the FDA to discuss this decision further."
Vanda has put on hold all iloperidone-related activities pending further review.
Source: Datamonitor
Related Articles
- Nektar Announces UCB's Cimzia(R) Approved by U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis
- UCB's CIMZIA(R) (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis
- FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia
- Network Intercept Releases Scan-on-the-Go(TM) Active State
- Ceragenix Completes Patient Visit Phase of Clinical Trial Study to Compare Efficacy of EpiCeram(R) to Elidel(R)
- Vanda Finds Iloperidone Effective Against Schizophrenia
- Preliminary Results of Randomized Pilot Study Show Comparable Efficacy for OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM) and Boston Scientific's Taxus(R) Stent in Patients at High Risk of Restenosis
- ARIXTRA(R) Showed Comparable Efficacy to LOVENOX(R)/CLEXANE(R) With Significantly Less Major Bleeding in Patients With Acute Coronary Syndromes
- Comparative Efficacy of Once Daily, 5-Day Short-Course Therapy With Clarithromycin Extended-Release Versus Twice Daily, 7-Day Therapy With Clarithromycin Immediate-Release in Acute Bacterial Exacerbation of Chronic Bronchitis*
- Symantec to Acquire Powerquest; Strengthens Symantec's Offering in Active State Management
 |
 |
User Comments (0)
RSS Feeds