Biogen’s Spinraza has been approved by the EMA for the treatment of spinal muscular atrophy in injectable form. The disease affects about 95% of all patients and is the leading genetic cause of death in infants.
Biopharmaceutical drug maker Dompé has received approval for Oxervate (cenegermin eye drops) for the treatment of adult patients with moderate or severe neurotrophic keratitis, a rare condition that can lead to vision loss. The Agency based their approval on data from two phase II clinical trials involving 204 patients with moderate and severe neurotrophic keratitis. Both studies showed that after 8 weeks, a higher number of Oxervate treated patients achieved healing compared to patients on placebo. Oxervate can lead to side effects such as eye pain, eye inflammation, increased lacrimation, eyelid pain and foreign body sensation in the eye.
Samsung Bioepis have announced the EMA has approved their drug Imraldi, a biosimilar of Humira for the treatment of various arthritic and psoriatic conditions. These include rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis. The approval is based on data obtained from a randomised, double-blind 52-week Phase III study of 544 patients. Patients with moderate to severe rheumatoid arthritis despite methotrexate therapy were randomised to either the Imraldi group or the adalimumab reference product (ADL). The response rate was greater in the Imraldi group than in the ADL group (72.4% vs 72.2%).
The following drugs have also been approved by the EMA:
Maviret (glecapervir/pibrentasvir): Abbvie’s Maviret for the treatment of hepatitis C. This is a combination of inhibitors of the viral proteins NS3/4A and NS5A
Vasovie (sofosbuvir/velpatasvir/voxilaprevir): Another hepatitis C treatment, from Gilead sciences. This is a competitive nucleoside inhibitor of NS5B protein in combination with a NS5A and a NS3/4 virus protease blocker.
Eculizumab: Alexion Therapeutics’ targeted antibody therapy has been approved to be used in a subpopulation of patients with generalised myasthenia gravis overexpressing the Ach receptor. The antibody targets complement protein 5.
Kisqali (riboclib): Novartis’ CDK4/6 blocker Kisqali has been approved as a novel treatment option for women with HER2-negative advanced or metastatic breast cancer, in combination with aromatase blocker standard therapy.
Fotivda (tivozanib): EUSA Pharma’s Fotivda has been approved for patients with advanced for renal cell carcinoma, a treatment not approved by the FDA in 2013 because of a negative benefit/risk balance.
Mavenclad (cladribine): Merck KGaA’s Mavenclad tablets have been approved for the treatment of relapsing forms of multiple sclerosis based on additional studies recommended by the EMA seven and six years ago, when Merck had withdrawn its MAA for the purine nucleoside analogon.
Mimpara (cinacalcet): Amgen’s Mimpara has been approved for the treatment of secondary hyperparathyroidism (HPT) in children aged three years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. The decision was based on data from studies Amgen began in 2007 to assess the use of Mimpara in paediatric secondary HPT patients with very few treatment options.