While it may well be the dog days of summer, European drug regulators are showing no signs of slowing down in their review of new medicines and proposed label expansions.
In a busy meeting this week, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) signed off on seven new medicines, six biosimilars and 11 label expansions for existing drugs. In addition, Accord's generic to Pfizer's tyrosine kinase inhibitor Inlyta gained a CHMP thumbs-up, according to CHMP's meeting summary.
Perhaps most notably, European regulators this week turned away Eisai and Biogen's Alzheimer's disease filing for Leqembi.
Conversely, Astellas' Vyloy (zolbetuximab) to treat gastric or gastro-oesophageal junction adenocarcinoma appears to be heading toward an EU approval. That drug suffered an FDA rejection early this year and is on track for a new approval decision in the U.S. by Nov. 9.
In addition, J&J's single-tablet combination of macitentan and tadalafil scored a CHMP endorsement for patients with pulmonary arterial hypertension. The drug combination scored FDA approval in March and is branded as Opsynvi in the U.S.
Besides those meds, new offerings from LEO Pharma, Ipsen, Novaliq and other companies made the grade at CHMP this week. LEO's Anzupgo snared an approval recommendation in chronic hand eczema, while TMC Pharma's June Biosciences-partnered cancer medicine Loqtorzi secured its own thumbs-up.
Ipsen, for its part, nabbed endorsements for two rare liver disease medicines: Iqirvo in primary biliary cholangitis and Kayfanda in Alagille syndrome.
As for existing meds, CHMP regulators signed off on the key first-line bladder cancer use for the combination of Merck's Keytruda and Pfizer and Astellas' Padcev, as well as for Roche's Tecentriq as a monotherapy in first-line non-small cell lung cancer in patients who are ineligible for platinum-based therapy, plus a host of other drugs.
Further, new biosimilars to Johnson & Johnson's Stelara, plus Roche's trio of Rituxan, Lucentis and Herceptin are heading to the European Commission (EC) with CHMP support.
After the CHMP meeting, all the recommendations now head to the EC for a final decision on approval.