European Regulators Endorse Multiple New Drugs, Vaccines in Busy Week

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for a slate of new medicines, including vaccines, oncology treatments, and biosimilars, signaling a productive week for the pharmaceutical industry in Europe.

Vaccines and Infectious Disease Prevention

Merck's pneumococcal vaccine Capvaxive received a positive opinion from CHMP for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults. The 21-serotype vaccine targets the majority of invasive pneumococcal disease cases in the adult population. Merck anticipates final marketing authorization from the European Commission in the second quarter of this year.

In a landmark decision, Bavarian Nordic's Vimkunya became the first chikungunya vaccine to receive a CHMP recommendation. The vaccine underwent an accelerated assessment under the EMA's PRIority MEdicines program, with the company planning to launch in key European markets in the first half of 2025, pending final approval.

Oncology Advancements and Biosimilars

AstraZeneca and Daiichi Sankyo's antibody-drug conjugate (ADC) Datroway earned CHMP backing for certain patients with unresectable or metastatic HR-positive, HER2-negative breast cancer. This recommendation paves the way for Datroway's third regulatory nod, following recent approvals in Japan and the United States.

Pfizer and Genmab's ADC Tivdak received a positive opinion for recurrent or metastatic cervical cancer, positioning it to become the first ADC approved for cervical cancer in Europe.

In the biosimilar space, CHMP endorsed three products: Dyrupeg, a biosimilar of Amgen's Neulasta by Aurobindo Pharma's CuraTeQ Biologics, and Amgen's own Pavblu and Skojoy, both biosimilars of Regeneron and Bayer's blockbuster eye drug Eylea.

Alzheimer's Treatment Reevaluation

The European review of Eisai and Biogen's Alzheimer's disease treatment Leqembi took an unexpected turn, with CHMP agreeing to consider new safety information at the European Commission's request. This development follows a restricted approval in November, which limited the drug's use to patients with one or no copies of the ApoE4 gene.