UK MHRA Clarifies No Deal Brexit Plans For PIPs
The Medicines and Healthcare products Regulatory Agency explains how it would deal with pediatric investigation plans if the UK leaves the EU with no deal.
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The decision by health technology assessment body NICE on Novartis’s advanced breast cancer drug, Kisqali, contrasts sharply with its recommendation for another CDK4/6 inhibitor – Lilly’s Verzenios.
The sponsors of seven new drugs are set to find out this week whether the European Medicines Agency’s human medicines committee, the CHMP, will recommend pan-EU approval for their products. CHMP action is also expected regarding two potential combination therapies for COVID-19.
Verzenios is one of three CDK4/6 inhibitors that are available via the Cancer Drugs Fund for use in previously treated patients with metastatic breast cancer, but it is the first for which health technology assessment body NICE has published a recommendation on routine commissioning.