Sanofi and Alnylam apply for EU approval of hATTR amyloidosis therapy

Sanofi and Alnylam Pharmaceuticals have applied for European regulatory approval for patisiran, a new investigational RNAi therapeutic targeting transthyretin.

The marketing authorisation application to the European Medicines Agency is intended to secure approval of the drug for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).

This submission was based on positive findings from the APOLLO clinical study, which have shown the drug's potential to become a new standard of care for this condition.

Patisiran has already been granted accelerated assessment status by the EU regulator, recognising the benefits this treatment could deliver for an underserved patient population.

Dr Rand Sutherland, therapeutic area head for rare diseases development at Sanofi, said: "We are one step closer to making patisiran available in Europe and executing on our shared vision to bring this RNAi treatment to patients globally."

Alnylam applied for US Food and Drug Administration approval of patisiran in December 2017. If approved, Alnylam will commercialise patisiran in the US, Canada and western Europe, with Sanofi Genzyme handling the rights across the rest of the world.

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