There's no ambiguity about this FDA staff review. In briefing docs on Chelsea Therapeutics' ($CHTP) bid to gain approval of its hypotension drug Northera (droxidopa), agency staffers recommended against approval, confirming investors' worries about the drug's prospects in the U.S. market.
The FDA staff noted the "worrisome" safety issues in clinical trials, including deaths, strokes, myocardial infarction and disease progression, according to the agency's briefing docs. Also sparking concern is a post-marketing study in Japan, where the drug is approved, that identified cases of a potentially deadly neurological condition known as neuroleptic malignant syndrome in patients who took the drug.
"On the basis of the safety concerns compounded by absence of evidence of durability of effect, my regulatory recommendation is that we should not grant approval for droxidopa [Northera] at this time," FDA staffers said in their report.
Chelsea's shares were down by 15.7% as of 11:46 am ET today. In fact, its share price has taken a beating since the company alerted investors last week the FDA had questions about the relatively small size of its clinical trials for the drug (along with other concerns). The drug is supposed to treat a drop in blood pressure that happens within three minutes of a patient standing up, Bloomberg reported, noting Dainippon Sumitomo Pharma markets the drug in Japan with annual revenue of $50 million.
Non-FDA experts are due to meet Feb. 23 to review Chelsea's Northera application and decide whether to recommend approval. The FDA doesn't have to--but often does--take such panels' recommendations, and the agency is expected to decide whether to stamp an approval on the drug by March 28.
- here's the Bloomberg article
- see the update from RTTNews