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December 3, 2019

Exservan is approved by FDA to address major unmet ALS need

By GlobalData Healthcare

The US Food and Drug Administration (FDA) has approved Aquestive Therapeutics’ Exservan (riluzole oral film) for the treatment of amyotrophic lateral sclerosis (ALS). ALS is a rare and fatal neurodegenerative disease that is characterised by progressive loss of motor neurons.

Exservan is a novel formulation of Sanofi’s Rilutek (riluzole), and historically this has been the standard of care for ALS patients as it secured the first-to-market position back in 1995.

The second drug to be approved for ALS was Mitsubishi Tanabe’s Radicava/Radicut (edaravone) in 2017.

Drugs are difficult to administer

However, both Rilutek and Radicava/Radicut have moderate efficacy at best, seeing that they can extend patient survival for up to six months. In addition, their respective route and frequency of administration are far from ideal for ALS patients. This means that, despite the rarity of the disease, there is a high level of unmet need in the market and significant opportunities for a pharmaceutical company to address.

Rilutek is an orally administered tablet that has to be given multiple times per day, which can be difficult for an advanced-stage ALS patient who has trouble swallowing.

Radicava/Radicut is an intravenously administered drug and, again, this may be difficult for patients who are suffering from mobility issues. Some companies have identified this gap in the market and have been developing reformulations to minimize these compliance problems.

New drug Exservan dissolves on the tongue

A case in point is provided by Aquestive Therapeutics, because it has successfully developed an oral soluble film version of Rilutek, which dissolves on the tongue once administered and does not require water or the muscle action to swallow. Exservan’s improved formulation is expected to translate into a higher compliance rate and provide the drug with an important clinical advantage.

As such, according to GlobalData, the new drug is forecast to generate $16M in US sales in 2025. Aquestive has recently licensed the drug to Zambon Pharma for the development and commercialization of Exservan in Europe. Under the deal, Aquestive will be responsible for manufacturing the drug, while Zambon will focus on regulatory approval and marketing in Europe. Given that Zambon is based in Italy and already has experience in neurology, this deal is expected to boost the commercial potential of Exservan even further.

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