|
AstraZeneca PLC on Monday said two drugs have been recommended for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency. The Cambridge, England-based pharmaceuticals company said its asthma drug Tezspire has been recommended for approval in the European Union for the treatment of adult patients with chronic rhinosinusitis with nasal polyps. Tezspire is being developed by AstraZeneca in collaboration with Amgen Inc, a Thousand Oaks, California-based biotechnology company. The recommendation is based on Waypoint phase III trial results showing Tezspire reduced nasal polyp severity and nasal congestion, nearly eliminated the need for surgery and significantly reduced systemic corticosteroid use versus placebo. The safety profile and tolerability of Tezspire in the trial were consistent with the known profile of the medicine, Astra said. Regulatory applications are currently under review in the US, China, Japan and several other countries based on the trial, it added. Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and more than 60 countries across the globe. In addition, AstraZeneca said Koselugo has been recommended for approval in the EU by CHMP for plexiform neurofibromas in adults with neurofibromatosis type 1. The recommendation is based on Komet phase III trial results which showed 20% objective response rate in tumour size reduction. The safety profile of Koselugo in trial was consistent with its known profile. The drug has recently been approved in Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable plexiform neurofibromas based on data from the trial, and additional regulatory reviews are ongoing. AstraZeneca is collaborating with Rahway, New Jersey-based pharmaceutical firm Merck & Co Inc to co-develop and co-commercialise/Koselugo. Shares in AstraZeneca were down 0.3% at 11,276.00 pence in London on Monday morning. The wider FTSE 100 index was down 0.1%. Copyright 2025 Alliance News Ltd. All Rights Reserved.
|
