CHMP recommends 12 new medicines, including first RSV treatment for infants

Regulatory NewsRegulatory News | 19 September 2022 |  By 

The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to prevent respiratory syncytial virus (RSV) in newborns, driving the total number of endorsed treatments to 70 since the beginning of the year. Five of the 12 approval recommendations are for orphan drugs.
The new RSV treatment, Beyfortus (nirsevimab) developed by AstraZeneca and Sanofi, was supported through EMA's PRIME scheme, which allows for early and enhanced regulatory support for unmet medical needs.
In its review, CHMP concluded that data from two randomized, double-blind, placebo-controlled  multicenter clinical trials demonstrated the treatment “prevents lower respiratory tract infection caused by RSV requiring medical attention (such as bronchiolitis and pneumonia) in term and preterm infants during their first RSV season.”
The five orphan drugs recommended for approval include Genzyme’s Enjaymo (sutimlimab) for treating anemia in adults; Takeda’s Livtencity (maribavir) for treating cytomegalovirus infection; Amryt Pharmaceuticals’ Mycapssa (octreotide) for treating acromegaly; and Agios Netherland’s Pyrukynd (mitapivat) for treating pyruvate kinase deficiency.
The last orphan drug recommended is ADC Therapeutics’ Zynlonta (loncastuximab tesirine), which received conditional marketing approval for treating patients with diffuse large B-cell lymphoma.
In addition, one biosimilar, STADA Arzneimittel AG’s Ximluci (ranibizumab) was recommended for treating neovascular age-related macular degeneration; and one hybrid medicine, Sun Pharmaceutical’s Teriparatide Sun (teriparatide) for treating osteoporosis.
Three generic medicines also were recommended for approval, with two of these treatments coming from one company, Accord Healthcare, for its Sorafenib (sorafenib) for treating hepatocellular carcinoma and renal cell carcinoma; and Teriflunomide Accord (teriflunomide) for treating multiple sclerosis. Mylan’s Teriflunomide Mylan (teriflunomide) also was recommended for treating multiple sclerosis.
In other actions, CHMP recommended extending the indications for 11 medicines: Leo Pharma’s Adtralza (tralokinumab); Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide); Beigene Ireland’s Brukinsa (zanubrutinib); AstraZeneca’s Evusheld (tixagevimab/cilgavimab); Pacira Ireland’s Exparel liposomal (bupivacaine); Novartis’ Revolade (eltrombopag); Abbvie’s Skyrizi (risankizumab); Merck Sharp & Dohme’s Vaxneuvance (pneumococcal polysaccharide vaccine); Gilead’s Veklury (remdesivir); Pfizer’s Xalkori (crizotinib); and Kite Pharma’s Yescarta (axicabtagene ciloleucel).
Two applications were withdrawn: Takeda’s Exkivity (mobocertinib) for non-small cell cancer; and Hutchmed Europe’s Sevsury (surufatinib) for treating progressive neuroendocrine tumors.
In other areas, CHMP confirmed its original recommendation to suspend marketing authorizations of several generic medicines tested by Synchron Research Services, a contract research organization (CRO) based in Ahmedabad, India.
EMA announcement


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