Idorsia In Dreamland With Insomnia Drug Approval
FDA Green Light For Daridorexant
The Swiss biotech has got the thumbs up in the US for its insomnia drug which will be sold as Quviviq and is expected to be provide serious competition for Merck & Co's rival dual orexin receptor antagonist Belsomra.
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The European Medicines Agency will likely decide this week whether to recommend for pan-EU approval new treatments for insomnia, uveal melanoma, migraine and advanced prostate cancer.
The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.
Despite the impact of the war in Ukraine and spiralling costs, as well as lower COVID-19-based revenues, the German group is forecasting a healthy financial performance for full-year 2022.