Keystone-SDA
The Committee for Human Usage Medicines (CHMP) recommends that they do not grant a marketing authorization for Elevidys (Delandistrogene Moxeparvevec), a treatment of the Basel giant Roche against Duchenne myopathy for patients aged 3 to 7.
(Keystone-ATS) The institution, which issues an opinion favorable or not on drugs then subject to the European Commission, explained on its website on Friday that the study did not demonstrate that Elevidys had an effect on patients’ movement capacities after twelve months. In addition, differences with placebo were not significant.
The CHMP specifies that currently, all the clinical trials conducted with Elevidys are temporarily paused and that no patient is treated with this therapy.
In a separate Roche press release said it was “disappointed” by the unfavorable opinion of the CHMP, “given the urgent need” of therapies for children living with this disease in the European Union, according to Levi Garraway, medical chief of the Giant Pharma. He says he is confident about the value that Elevidys can bring to patients. To date, 900 people, including 760 on an outpatient, have been treated with Elevidys.
In June, Roche had ceased the treatment with his Elevidys genetic therapy of patients with this disease and no longer being able to move, following the death of two patients.
The treatment, developed by his partner Massachusseais Sarepta Therapeutics, has already obtained the green light from the health authorities in the United States, in the United Arab Emirates, in Qatar, Kuwait in Bahrain, Oman, Brazil and Israel.
Duchenne myopathy is a rare genetic disease, which appears in childhood and causes a progressive weakening of the muscles.
Around 1:05 p.m., the good rock lost 0.9% to 262.70 francs, in a SMI down 0.5%.