Amgen Bows Out Of Partnership With AstraZeneca On Phase III Brodalumab
This article was originally published in The Pink Sheet Daily
Company drops deal to co-develop and commercialize the IL-17 blocker in psoriasis, cites reports of suicidal ideation.
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Agency's advisors were divided on whether Valeant's proposal for voluntary registry would suffice or whether mandatory program under REMS was needed to better assess risk of suicide and suicidal behavior with psoriasis drug.
Advisory committee will hear agency reviewers' different conclusions on plaque psoriasis drug's approvability due to potential psychiatric effects and whether a REMS can help mitigate the risks.
Amgen and the AstraZeneca biologics subsidiary will co-develop and commercialize five monoclonal antibodies in inflammation and respiratory indications, led by brodalumab, which recently posted impressive Phase II data in psoriasis.