Marketing Authorisation

AbbVie receives marketing authorisation from EC to shorten MAVIRET duration for treatment-naïve genotype 3 HCV patients with compensated cirrhosis

AbbVie said that the European Commission has approved a change to the marketing authorization for MAVIRET (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection.

Alnylam gets EC nod for Givlaari to treat acute hepatic porphyria

Alnylam Pharmaceuticals has secured marketing authorisation from the European Commission (EC) for its Givlaari (givosiran) to treat acute hepatic porphyria (AHP) in adults and adolescents aged 12 years and older.

Pfizer’s VYNDAQEL gets EC approval for treatment of ATTR-CM

Pfizer has secured European approval for its oral transthyretin stabilizer VYNDAQEL (tafamidis) for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Bristol-Myers Squibb withdraws European application of Opdivo plus Yervoy for first-line treatment of advanced NSCLC

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the company has withdrawn its application in the European Union (EU) for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227.

European Medicines Agency validates Kite’s marketing application for second CAR T cell therapy

Kite, a Gilead Company announced that the company’s Marketing Authorization Application (MAA) for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), has been fully validated and is now under evaluation by the European Medicines Agency (EMA).

Novartis’ Mayzent gets EC nod for secondary progressive multiple sclerosis

Novartis has secured approval for Mayzent (siponimod) in the European Union (EU) for the treatment of secondary progressive multiple sclerosis (SPMS) in adults.

EC approves two new regimens of Merck’s KEYTRUDA for metastatic or unresectable recurrent HNSCC

Merck, known as MSD outside the US and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1).

Astellas’ gilteritinib secures EC approval to treat acute myeloid leukaemia

Astellas Pharma’s Xospata (gilteritinib) has secured approval from the European Commission (EC) as a monotherapy for the treatment of acute myeloid leukaemia (AML).

CHMP recommends Tecentriq, chemotherapy combo for NSCLC and ES-SCLC

Roche’s Tecentriq (atezolizumab) and chemotherapy combination has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of two types of lung cancer.