The European Medical Agency (EMA)鈥檚 Committee for Medicinal Products for Human Use (CHMP) has recommended eight medicines for approval at its February meeting; the last in its London headquarters before the agency moves to Amsterdam as a result of Brexit.
Three of the medicines were granted conditional marketing authorisation, meaning the manufacturer must provide comprehensive clinical data related to the product in the future.
These are Portola Netherlands鈥� Ondexxya (andexanet alfa), an antidote for adult patients taking anticoagulants apixaban or rivaroxaban, Akcea Therapeutics鈥� Waylivra (volanesorsen), the first medicine to treat rare genetic disorder chylomicronaemia syndrome. As well as 鈥檚 Lorviqua (lorlatinib) indicated for anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (NSCLC).
Three products were granted a positive opinion by the CHMP, a crucial step towards final marketing authorisation by the European Commission. The products are BioMarin鈥檚 Palynziq for patients aged 16 and above with rare, inherited metabolic disease , as well as Zynquista (sotagliflozin), an adjunct to insulin for certain type 1 diabetes patients, and Skyrizi (risankizumab) indicated for psoriasis.
The remaining two medicines recommended were GlaxoSmithKline鈥檚 Dectova (zanamivir), which was granted marketing authorisation in exceptional circumstances for complicated influenza, and Teva鈥檚 generic Pazenir (paclitaxel) indicated for metastatic breast cancer and NSCLC.
The CHMP also recommended an extension of therapeutic indication for five drugs, including 鈥檚 Dupixent as an add-on maintenance treatment for patients 12 years and older with rare forms of asthma.
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By GlobalData鈥檚 Lynparza, 鈥檚 Riarify and Trydonis, as well as Gilead鈥檚 Viread, also saw indication extensions. Breast cancer was added to Lynparza鈥檚 indications, Riarify and Trydonis can now treat a larger chronic obstructive pulmonary disorder patient group, and hepatitis B was added to Viread鈥檚 indications.
CTI Life Sciences withdrew its application for marketing authorisation for Epjevy (pacritinib citrate) to treat symptoms of myelofibrosis in patients with thrombocytopenia. The EMA said that before the withdrawal, the CHMP had some concerns about the effectiveness of the drug and it could not have been approved for this indication.
The company withdrew Epjevy on the basis it could not generate additional data required to support a successfully CHMP opinion in the required timeframe.
