FDA rejects Biohaven treatment for Lou Gehrig’s disease


2019-07-23 16:09:00 pharmamanufacturing


Biohaven Pharmaceutical Holding Co. has reported that its new treatment for armyotrophic lateral sclerosis, or Lou Gehrig’s disease, has failed to win FDA approval.  The company announced Friday that the FDA said in a complete response letter that it is concerned about an API that was used in a 2017 study of the drug, Nurtec, that was produced by Apotex Pharmachem India, who had been in communication with the FDA about qualifying certain batches. The company said it is now sourcing the API from another supplier and that it is working with the agency to resolve the matter. Biohaven’s Nurtec is a generic sublingual form of riluzole, which is used to treat ALS. But because many ALS patients have trouble swallowing, Biohaven believes the sublingual delivery will give it an edge in the market.   
Biohaven Pharmaceutical Holding Co .报告称,其针对扶手型外侧硬化症( Lou Gehrig's disease )的新疗法未能获得 FDA 的批准。 该公司上周五宣布, FDA 在一份完整的回复信函中表示,它关注的是一种原料药,该原料药用于2017年由 Apotex Pharmachem India 生产的药物 Nurtec 的研究, Apotex Pharmachem India 曾与 FDA 就某些批次的合格问题进行过沟通。 该公司表示,目前正在从另一家供应商采购原料药(API),并正在与该机构合作解决此事。 Biohaven ’ s Nurtec 是一种用于治疗 ALS 的利鲁唑的通用舌下形式。但由于许多 ALS 患者吞咽困难, Biohaven 认为舌下给药将使其在市场上占有优势。