Valeant announces FDA acceptance of BLA submission for brodalumab in moderate-to-severe plaque psoriasis
The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies.
Valeant Pharmaceuticals International has announced that FDA has accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant, for brodalumab injection, 210 mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate-to-severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of 16 November 2016.
The Marketing Authorisation Application (MAA) for brodalumab in psoriasis was accepted by the European Medicines Agency (EMA) in Q42015. In October, 2015, Valeant entered into a collaboration agreement with AstraZeneca under which Valeant has an exclusive license to develop and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd.
The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies. The results highlighted that brodalumab has an effective mechanism of action that could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210 mg dose, brodalumab was shown to be effective in total skin clearance of psoriasis compared to placebo and superior to ustekinumab, a leading approved psoriasis treatment, at week 12 in two replicate comparator trials involving over 3,500 patients.
Related News
-
News Introducing the Pharmaceutical Sustainability Ecosystem from CPHI
The Sustainability Collective from CPHI unveils the groundbreaking Pharmaceutical Sustainability Ecosystem to drive pharmaceutical knowledge sharing, connection, and collaboration in order to change the face of sustainability in pharmceutical... -
News US Government shutdown leads to the FDA grinding to a halt
The US Congress reached a deadlock after not being able to come to an agreement regarding funding, specifically reaching an impasse when Republicans and Democrats were unable to reach an agreement regarding Obamacare subsidies. The resulting shutdown o... -
News Biosimilars for the better: an expert view from Ecolab
Ecolab expert Renato Azevedo shares his insights on the current state of the biosimilars market in pharmaceuticals, after a high number of biosimilar drug approvals throughout the year confirming the shift of focus in this field. -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News CPHI Podcast Series: US drug policy – exploring the executive orders
The latest episode of the CPHI Podcast Series provides a timely overview of the recent policy changes in the USA, with President Trump signing excecutive orders to change drug pricing under a 'Most Favoured Nation' scheme.
-
News PhRMA trade association issues comments on Section 232 investigation
The Pharmaceutical Research and Manufacturers of America (PhRMA), an American trade association representing groups in the pharmaceutical industry, issued a letter on May 6, 2026 to the Department of Commerce regarding the Section 232 National Security... -
News Pharmaceutical Packaging Market Prospects: Shifting regional policies
The pharmaceutical packaging industry is experiencing significant transformation in 2025, driven by regulatory changes, supply chain challenges, and sustainability initiatives. The US BIOSECURE Act, passed through the House of Representatives in Septem... -
News The next 15 drugs up for negotiation with Medicare include several blockbusters
By now, everyone is quite familiar with the drug price negotiations taking place between drug companies and the Centres for Medicare & Medicaid Services (CMS) in the USA as part of measures being taken to reduce the cost of drugs for patients, to make ...