Roche Seeks Speedy EMA Review For SMA Drug Risdiplam
Applications to market Roche’s spinal muscular atrophy drug have already been submitted in eight countries including the US, where a decision is due in August.
You may also be interested in...
Two products that were under fast-track review at the European Medicines Agency have reverted to standard review timelines – Eiger's lonafarnib and GSK's dostarlimab. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.
Pharma and the US biotech will target key regulators of cellular metabolism with focus on immune and neurological disorders. Royalty Pharma buys portion of PTC’s royalty rights to risdiplam, under development at Roche.
At least another four investigational therapies will join the few that are already being fast-tracked at the European Medicines Agency.