Aquestive nabs FDA OK for oral film version of generic ALS drug
The FDA has given Aquestive Therapeutics the green light to market Exservan, its oral film formulation of a decades-old treatment for amyotrophic lateral sclerosis.
Back in 1995 riluzole became the first FDA-approved therapy for ALS, which remains incurable. Its exact mechanism of action is unknown but it’s been proposed that the drug blocks the release of glutamate from nerve cells, thereby alleviating glutamate-induced deterioration. As a result, the original drug was shown to delay symptoms and even death.
While the branded version, Rilutek, is still on the market (Covis Pharma bought the US rights a few years ago, and Sanofi retains worldwide control), Aquestive’s bigger challenge will be competing against generics, which can cost as little as $74.06 for 60 tablets on GoodRx.
But the biotech contends it’s targeting a specific patient group, which could open up a sizable opportunity. Shares $AQST are up 20.22% to $7.73 pre-market.
“Patients suffering from this debilitating neurodegenerative disease often find swallowing to be difficult or impossible,” CEO Keith Kendall said last year, when they secured orphan designation for the oral film. “To help manage one element of this challenging disease for people with ALS and their caregivers, we developed riluzole OSF to dissolve instantly in the mouth without water, using our proprietary PharmFilm technology.”
The New Jersey-based company, which has established its commercial presence with three previous products, has indicated that it plans to roll out Exservan by the end of the year. Italy’s Zambon is handling the European side of things after signing a licensing deal days ago.
We have an inquiry out to Aquestive regarding their pricing strategy and will update once we have an answer.