Chelsea Therapeutics‘s (NASDAQ:CHTP) drug candidate Northera failed in its bid to secure U.S. Food and Drug Administration approval.
But a door to approval remains cracked open for the company. The FDA’s complete response letter asks for more data on the durability of Northera over a two- to three-month period. Chelsea said it plans to use data from an ongoing study and believes that data from this trial could address the FDA’s efficacy and durability questions.
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Charlotte, North Carolina-based Chelsea is developing Northera to treat neurogenic orthostatic hypotension, a low blood pressure disorder that leads to dizziness and fainting in patients who have Parkinson’s disease, multiple systems atrophy or pure autonomic failure. NOH is a rare condition with few treatment options and the compound was granted orphan drug status and priority review.
Northera’s durability was among the concerns raised in the initial FDA review of the compound. The FDA reviewer said that although Northera was successful in one clinical trial, the study did not demonstrate that compound’s effects lasted longer than four weeks. The review ultimately recommended against approval of the drug. An independent advisory committee to the FDA last month voted 7-4 in favor of approving Northera.
But the FDA did give signs of what it needs to see in order to grant approval to Northera. Besides asking for additional clinical data, Chelsea said that the FDA indicated it needs more bioequivalence work done to support that 300 mg capsule that the company was considering to complement the 100 mg and 200 mg capsules used in clinical trials. But Chelsea added that this work would not be required for the drug’s approval. The FDA also provided draft recommendations for the drug’s labeling. The agency is recommending a black box warning related to supine hypertension. But that warning could be reconsidered if Chelsea can provide suitable data.
Chelsea plans to request a meeting with the FDA to review the agency’s comments and recommendations, and to plan the company’s next steps. If approved, Northera would become Chelsea’s first commercialized drug. While the company did not get the approval it wanted, it did get FDA guidance on how to get that approval. Chelsea still needs to make good on the information requests from the FDA. But rather than an outright rejection of Northera, the FDA action as of now is more of a delay.
