Here’s something that you don’t see every day…..
We published the report below in November 2019 detailing the approval of Exservan, a drug first approved twenty-five-years ago. Well, it is back in the news. Specifically, Mitsubishi Tanabe Pharma America, just announced that it is now changing its marketing strategy and is pushing this product into limited distribution. It has selected PANTHERx Rare as their exclusive specialty pharmacy provider of this oral film product.
That FDA approval was originally given to Aquestive Therapeutics. The shift to Mitsubishi may be the catalyst behind the change in access strategy.
There was uncertainty about the cost of Exservan when it was approved. It is now priced on par with its primary competitor, Tiglutik (oral suspension). The current cost for Exservan oral film 50 mg is around $3,291 for a supply of 60 films.
FDA Approves New Form of a 25-Year-Old Drug – Exservan
The FDA just approved a new (actually not so new) therapy for a very under served disease, amyotrophic lateral sclerosis (ALS). The approval was for an oral film version of a therapy, Riluzole, that was approved in 1995….. yes, 24 years ago!
Riluzole is a generic of the brand drug Rilutek, which is still on the market. The brand runs about $35,000 a year while the generic is now only $10,000 annually. Both, however are in tablet form, which presents a real challenge for patients that can’t easily swallow.
Before you ask why we are covering the approval of a copy of a very old drug let me explain.
In 2017 the FDA approved a next generation therapy for ALS, Radicava, which now costs about $145k annually. However, Radicava is IV therapy requiring multiple infusions per month….. and that presents access challenges for the majority of ALS patients who are not ambulatory. As such, Radicava hasn’t had much uptake.
Then, in 2018, the FDA approved Tiglutik, a form of Riluzole (yes, the same old generic). Tiglutik is an oral suspension….. easier for ALS patients to take…. but requires the patient or care giver to use a syringe to slowly drip-drip the medication into the mouth. The cost of Tiglutik, however, is $25k annually (2.5X the cost of the generic oral tablet form). (NOTE: The cost of Tiglutik has risen more than $10,000 since 2019.)
Finally we reach the end of this now convoluted story….. Exservan.
Because it is an oral film, Exservan can be easily administered to an ALS patient allowing the medication slowly dissolve under the tongue. While pricing hasn’t been announced it is likely to be in line with Tiglutik.