Roche announced Friday that the Committee of Human Use Medication (CHMP) of the European Medicines Agency (EMA) had given a negative opinion concerning the conditional recording of its Elevidys gene therapy in the treatment of Duchenne muscular dystrophy.
The CHMP held that the results of the phase 3 study were insufficient, its main objective having not been achieved after a year, even if Elevidys still showed significant and significant improvements on other physical operating criteria compared to the placebo, specifies Roche in a press release.
Roche, which argues that the average life expectancy of people with this myopathy is only 28 years old, explains that he intends to continue working with the European Health Agency because of the unsatisfied needs of patients.
The laboratory adds to date, more than 900 people with DMD, including 760 capable of walking, have been treated with Elevidys, whether in the context of clinical trials or in real conditions.
This announcement led to a drop in Roche action on the Zurich Stock Exchange where the title ceded 0.8% at lunchtime. The value has increased by around 3% since the start of the year.