Drug de­vel­op­er sues FDA over de­layed de­ci­sion on nar­colep­sy drug

A drug de­vel­op­er is su­ing the HHS, the FDA and both its chiefs, FDA Com­mis­sion­er Robert Califf and HHS Sec­re­tary Xavier Be­cer­ra, over a year­long de­lay in ap­prov­ing a nar­colep­sy drug.

Mis­souri-based Avadel CNS Phar­ma­ceu­ti­cals filed the suit in US Dis­trict Court in Wash­ing­ton DC ac­cus­ing the agen­cies of stalling. The suit is based on whether the drug would in­fringe on one of the patents that pro­tect Jazz Phar­ma­ceu­ti­cals’ treat­ment for nar­colep­sy Xy­wav — which has been a pri­ma­ry treat­ment since 2002 and is dis­trib­uted un­der a Risk Eval­u­a­tion and Mit­i­ga­tion Strat­e­gy, or REMS.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.