Several medicines are poised to reach new heights after winning key endorsements from European drug regulators.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) gave its thumbs-up to eight new medicines including two vaccines, two oncology drugs, three biosimilars and one generic, plus a parasite med that was cleared under a special program that allows it to reach populations beyond Europe.
The European review saga of Eisai and Biogen’s Alzheimer’s disease med Leqembi also got a CHMP update, with the agency agreeing to consider the European Commission’s request to consider safety information that came out after its November approval. That nod, which covers a restricted population of only patients who have one or no copies of the ApoE4 gene, came after Eisai requested a reevaluation after a previous rejection in July.
In vaccines, Merck’s pneumococcal disease vaccine Capvaxive was recommended for approval to protect adults from invasive disease and pneumonia caused by streptococcus pneumoniae bacteria. The vaccine was specifically designed for adults as the 21 serotypes it covers are responsible for the majority of invasive pneumococcal disease cases in that population.
With CHMP endorsement in hand, Merck looks to win final marketing authorization from the European Commission in the second quarter of this year, according to a company press release. Already in the U.S., Capvaxive is going up against Pfizer's 20-serotype Pfizer 20, which won European approval in March.
Bavarian Nordic’s chikungunya vaccine Vimkunya takes the title of the first chikungunya vaccine recommended by CHMP following an accelerated assessment under the EMA's PRIority MEdicines program. The company expects to launch the product in key European markets in the first half of 2025, pending final marketing authorization, it said in a release.
Two oncology treatments also received CHMP’s blessing. AstraZeneca and Daiichii Sankyo’s antibody-drug conjugate (ADC) Datroway was recommended for certain patients with unresectable or metastatic HR-positive, HER2-negative breast cancer, setting the TROP2-targeted med up for its third nod since winning recent approvals in Japan and the U.S. The companies recently pulled their application for Datroway in non-squamous non-small cell lung cancer, citing CHMP feedback.
Pfizer and Genmab’s ADC Tivdak won backing in recurrent or metastatic cervical cancer, teeing it up as the first ADC for cervical cancer to hit Europe pending final authorization.
As for biosimilars, CHMP regulators signed off on Dyrupeg, a copycat of Amgen’s post-chemo infection prevention Neulasta by Aurobindo Pharma’s CuraTeQ Biologics, plus Amgen’s Pavblu and Skojoy. The latter two are Amgen’s duplicate versions of Regeneron and Bayer’s blockbuster eye drug Eylea.
Accord’s eltrombopag, a generic to Novartis’ Revolade, also scored a positive CHMP opinion for the treatment of primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C.
Elsewhere, a fixed-dose combination of antiparasitic meds Ivermectin and Albendazole developed by Laboratorios Liconsa was cleared under the EU-M4All pathway, meaning that the European decision on the drug can apply to target countries outside of the region in need of the drug. The positive CHMP opinion goes to streamline World Health Organization prequalification and facilitates national registration of the treatment in certain countries.
Finally, CHMP recommended various indication extensions to eight currently approved medicines in Bristol Myers Squibb’s Breyanzi, Yervoy and Opdivo, AstraZeneca’s Imfinzi, Regeneron and Roche’s Ronapreve, Otsuka and Lundbeck’s Rxulti (marketed as Rexulti in the U.S.) , Merck’s Sivextro and Neurim Pharmaceutical’s Slenyto.
As for withdrawals, Advanz Pharma in December took back (PDF) its application for classic galactosaemia drug Nugalviq, requesting more time to collect further data to support the EMA’s review.