Canadian biopharmaceutical firm Neurochem said yesterday that the FDA has issued an approvable letter regarding its developmental amyloid A amyloidosis (AAA) treatment Kiacta.
AAA has no currently approved treatments.
The letter requests additional safety and efficacy data on Kiacta (eprodisate), which the agency said would need to be produced either through another clinical trial or additional follow-up of patients in the existing study.
However, Neurochem claims it is confident that it can satisfy the agency's requirements without another trial, a bullish stance that helped its share price advance 22% yesterday to close at C$13 on the Toronto Stock Exchange. It also aims to file for approval of the product in Europe in September.
Kiacta is partnered with Johnson & Johnson subsidiary Centocor, which has exclusive worldwide distribution rights to the product with the exception of Canada, Switzerland, Japan, China, South Korea and Taiwan.
Source: PharmaTimes
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