As part of its acquisition of Reata Pharmaceuticals, Biogen will add the first US Food and Drug Administration (FDA)-approved treatment for Friedreich’s ataxia to its portfolio.
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Biogen has agreed to acquire Reata Pharmaceuticals for a total of $7.3 billion.
This follows the first and only approved treatment for rare neuromuscular disease Friedreich’s ataxia authorised by the US Food and Drug Administration (FDA) in February 2023. Reata Pharmaceuticals’ orphan drug SKYCLARYS® (omaveloxolone) is under review by the European Medicines Agency (EMA) for market authorisation in Europe.
SKYCLARYS, an oral, once-daily small molecule semisynthetic triterpenoid, is indicated for treating Friedreich’s ataxia in adults and adolescents 16 years old and over in the US. It acts as an activator of nuclear factor (erythroid-derived 2)-like 2 (Nrf2), a transcription factor that mitigates oxidative stress.
Christopher Viehbacher, Biogen’s President and Chief Executive Officer commented on the company’s acquisition: “SKYCLARYS is an excellent complement to our global portfolio of treatments for neuromuscular and rare disease”.
“… we believe Biogen will establish SKYCLARYS as the standard of care in the treatment of this devastating genetic disease,” Warren Huff, Chairman and Chief Executive Officer of Reata stated.
The acquisition deal between Biogen and Reata Pharmaceuticals is subject to customary closing conditions, including approval by Reata stockholders and the receipt of necessary regulatory approvals. This transaction is anticipated to close in the fourth quarter of 2023.
What is Friedreich’s ataxia?
Friedreich’s ataxia is an ultra-rare, genetic and degenerative neuromuscular disorder. It is normally caused by a trinucleotide repeat expansion in the first intron of the frataxin gene. This encodes the mitochondrial protein frataxin.
Biogen’s recent development and commercialisation of drugs for rare diseases
In April 2023, the US FDA granted accelerated approval for QALSODY™ (tofersen) for SOD1-ALS. This is the first treatment to target a genetic cause of amyotrophic lateral sclerosis (ALS).
Additionally, in June 2023, Biogen announced new data from the Phase IV RESPOND trial highlighting potential benefit of SPINRAZA® (nusinersen) in infants and toddlers after Zolgensma® (onasemnogene abeparvovec) gene therapy treatment.
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