- Salix's NDA for crofelemer in HIV-associated diarrhea assigned priority review status
- Genentech's BLA for pertuzumab receives priority review status in previously untreated HER2-positive metastatic breast cancer indication
- FDA reviewers questions efficacy of NeurogesX's Qutenza pain patch in proposed new use
- Shire's Vyvanse approved for maintenance treatment in adults with ADHD
- FDA accepts Ziopharm's IND application for oral formulation of Zymafos
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
Fingolimod granted priority review status for treatment of MS
Wednesday, March 03 2010 | Comments
What's This?
The Food and Drug Administration granted the investigational multiple sclerosis (MS) drug fingolimod priority review status. Novartis AG submitted a New Drug Application for the drug in December requesting approval for the 0.5 mg/day dose. If approved, it would become the first oral therapy for the treatment of MS and would be marketed under the brand name Gilenia.
The company said the FDA would most likely require that an advisory panel convene to evaluate the risk-management program for the drug, which could result in the agency extending its review at the end of the 6-month period in June.
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