Drugs for ALS, age-related macular degeneration, and Duchenne muscular dystrophy did not get the green light due to lack of evidence.
The European Medicines Agency's Committee for Medicinal Products for Human Use has given negative opinions for two drugs intended to treat, a medicine intended to treat ALS . Its active substance, masitinib mesylate, is a protein kinase inhibitor that blocks enzymes involved in various immune-mediated inflammatory processes. The expectation was that this would reduce inflammation and protect nerve cells from damage, thereby slowing the worsening of ALS symptoms.
The European Medicines Agency's opinion therefore was that the benefits of masitinib did not outweigh its risks. There are no consequences for patients in ongoing clinical trials with the drug, and the company may ask for reexamination of the opinion within 15 days.; Apellis Europe B.V.), a drug intended to treat geographic atrophy secondary to AMD.
The CHMP said that although the results showed that pegcetacoplan did slow the growth of lesions, this did not lead to clinically meaningful benefits for patients. Given the risks of regular injections into the eye, the CHMP said that a positive balance of benefits and risks could not be established, and it recommended refusing marketing authorization.
Last month, the European Commission had asked the CHMP to further consider whether new data from a scientific advisory group on neurology convened in March this year affected its conclusions on the medicine's benefit-risk balance.
Muscular Atrophy Muscular Atrophies Drug/Treatment Safety Drug Safety Treatment Safety Drug Regulation Drug Registries Drug Registry Drug Legislation Drug Development Drug Discovery Drug Pipeline Drug Development Pipeline Amyotrophic Lateral Sclerosis ALS Lou Gehrig's Disease Maladie De Charcot Retinal Disease Dystrophinopathies Duchenne Muscular Dystrophy
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