Roche said two-thirds of spinal muscular atrophy (SMA) patients taking the Swiss drugmaker’s newly approved medicine Evrysdi have previously received rival treatments Zolgensma from Novartis or Biogen’s Spinraza.
A look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.
The U.S. Food and Drug Administration approved an oral treatment from Roche Holding AG and PTC Therapeutics Inc. for spinal muscular atrophy in adults and children two months and above.
One of medicine’s costliest treatment areas could become even more pricey as Biogen seeks to layer the company’s $750,000 spinal muscular atrophy drug on top of the $2.1 million-per-patient Novartis gene therapy Zolgensma.
Biogen announced new data from the NURTURE trial of pre-symptomatic patients with spinal muscular atrophy (SMA).
Roche company Genentech presented one-year data from FIREFISH Part 2, a pivotal trial of risdiplam in infants one to seven months old with symptomatic Type 1 spinal muscular atrophy (SMA).
Biogen reported full-year 2019 financial results, citing total revenues of $14.378 billion, an increase of 7% from the previous year.
Roche company Genentech announced positive top-line results from the pivotal Part 2 of the FIREFISH study looking at risdiplam in infants aged 1-7 months with Type 1 spinal muscular atrophy (SMA).
Roche is expecting the U.S. Food and Drug Administration to approve the company’s SMA therapy risdiplam by May 24, 2020, and has suggested plans to undercut both Biogen and Novartis on price in order to make up for being third-to-market.
Novartis aims to give away 100 doses of the company’s $2.1 million-per-patient Zolgensma for spinal muscular atrophy (SMA) in 2020 in a free-drug program that one patient group worried was a “health lottery” that could neglect some babies.