Daiichi Sankyo Seeks Approval to Market Radicava in Brazil

Daiichi Sankyo is looking to market the amyotrophic lateral sclerosis (ALS) treatment Radicava (edaravone) in Brazil after reaching a licensing agreement with the therapy’s maker, Mitsubishi Tanabe Pharma.

The company will submit a regulatory application through its local subsidiary, and expects to commercialize Radicava in the country upon approval, it announced in a news release.

Besides this agreement, Daiichi Sankyo also acquired the rights to market the available intravenous infusion formulation of Radicava in Central and South America countries other than Brazil, as well as other formulations in countries in the same region, including Brazil.

Radivaca is a free radical scavenger, meaning that has the capacity to remove potentially damaging free radicals — byproducts of energy production in cells — that can lead to nerve cell death and muscle atrophy (shrinkage) in ALS.

After Radicava was initially approved in Japan and South Korean in 2015 to treat ALS, the U.S Food and Drug Administration followed with its approval in 2017, where the therapy is now commercialized by Mitsubishi Tanabe Pharma America. One year later, Health Canada reached a similar decision approving the use of Radicava in the country to treat ALS patients. Switzerland and China are the two other countries where this treatment has been approved.

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However, Mitsubishi Tanabe Pharma withdrew an application to obtain marketing authorization for Radicava in the E.U. in May. It based this decision on the opinion of the Committee for Medicinal Products for Human Use — an arm of the European Medicines Agency — which stated that available clinical data did not represent a positive benefit-risk balance for ALS patients and that the application lacked evidence of improvements in survival, breathing, and muscle strength to support the treatment’s approval.

However, ALS patients in the E.U. may access the therapy through an early access program provided by Clinigen Group in collaboration with Mitsubishi Tanabe Pharma.

Mitsubishi Tanabe Pharma is looking to broaden the countries where Radicava is available. The company is also working on an oral formulation as an alternative to the current intravenous delivery route.

Until Radicava’s approval, ALS patients had one therapy available on the market — Rilutek (riluzole, by Sanofi), given as oral tablets — that was approved in the U.S. in 1995. An oral suspension of riluzole became available in the U.S. in 2018, and is marketed by ITF Pharma with the brand name Tiglutik.