Pf rounds-up this week’s pharma drug approvals and appraisals from the UK, Europe and USA.
Janssen’s Spravato (Esketamine) with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor is not recommended by NICE, within its marketing authorisation, for adults with treatment-resistant depression that has not responded to at least two different antidepressants in the current moderate to severe depressive episode.
NICE has published draft guidance recommending upadacitinib (Rinvoq, AbbVie) as an option for treating severe rheumatoid arthritis. The guidance is open for public consultation until 21 February 2020.
Janssen announced that the European Commission has granted a licence extension for Erleada®▼ (apalutamide) making it licensed for adult men in the UK with metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy.
Kite, a Gilead Company announced that its marketing authorisation application 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, has been validated and is now under evaluation by the European Medicines Agency.
Daiichi Sankyo announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted positive opinions for the marketing authorisations of both bempedoic acid and the bempedoic acid/ezetimibe fixed dose combination tablet, recommending their approval as treatments to reduce low-density lipoprotein cholesterol.
The FDA has approved a new drug application (NDA) for MSD’s DIFICID® (fidaxomicin) for oral suspension, and a supplemental new drug application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.
Roche has completed a supplemental biologics license application submission to the FDA for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
The FDA has approved a label update for Novartis’ Cosentyx® (secukinumab) to include the option for up-titration to a 300 mg dose for adults with active ankylosing spondylitis.