Cancer, COVID-19 and copycat drugs dominated the agenda at last week's meeting of the European Medicines Agency’s (EMA's) human medicines committee, which has endorsed four new pharmaceuticals and pushed for label extensions on 11 others.
AstraZeneca and Sanofi were the biggest winners this time around, nabbing three and four approval recommendations, respectively. The EMA’s Committee for Medicinal Products for Human Use (CHMP) also put its chips behind drugs and vaccines from GSK, Roche, Viatris, Regeneron and Bayer, among others.
CHMP’s recommendations aren’t a formal approval, but they often precede marketing authorization from the bloc’s high authority, the European Commission.
As for AZ’s recent regulatory triumph, the British drugmaker has received a thumbs-up on potential label expansions for its oncology trio of Lynparza, Imfinzi and Enhertu.
PARP inhibitor Lynparza received a CHMP endorsement to treat adults with metastatic castration-resistant prostate cancer who aren’t eligible for chemotherapy. Imfinzi’s recommendation, meanwhile, included a chemotherapy component and, if approved, would mark the first immunotherapy regimen cleared in Europe for advanced biliary tract cancer.
Finally, AZ’s Daiichi Sankyo-partnered Enhertu won the CHMP’s blessing as a solo therapy for adults with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who’ve received prior treatment with a regimen involving trastuzumab, sold by Merck & Co. as Ontruzant.
Sanofi, for its part, won support for new nods on its approved heart meds DuoPlavin and Plavix as well as its immunology cash cow Dupixent and its GSK-partnered COVID-19 vaccine booster VidPrevtyn Beta. The European Commission subsequently approved VidPrevtyn Beta, marking the partners’ first win in a drawn-out struggle to muster a coronavirus shot.
Where Sanofi and Regeneron’s Dupixent is concerned, the antibody is in the running to treat chronic inflammatory skin condition prurigo nodularis, winning CHMP’s support on the merits of two pivotal trials showing the drug “significantly” improved itch, skin lesions and health-related quality of life in adult patients. Dupixent is already approved in prurigo nodularis in the U.S. Across the pond, Sanofi expects European regulators to issue their decision on the new indication “in the coming months.”
Other approved drugs receiving recommendations for new uses included Pfizer and BioNTech’s mRNA vaccine Comirnaty, which CHMP has vouched for in children between 5 years and 11 years old. Regeneron and Bayer’s Eylea also won a vote of confidence, this time in a bid to treat preterm infants with retinopathy of prematurity.
Globally, it is estimated that each year approximately 50,000 babies born prematurely, who survive the neonatal period, develop vision-threatening ROP, Bayer pointed out in a release. In more serious cases, ROP can lead to blindness secondary to retinal detachment.
Aside from those products, the committee backed biosimilars and generics for osteoporosis, pulmonary fibrosis and more.
On the whole, it’s been an eventful few weeks at the EMA, with a number of high-profile recommendations coming down the pipe. Back in mid-October, CHMP put in a good word for Takeda’s dengue fever vaccine Qdenga one month after its first global approval in Indonesia. The Japan-based pharma expects the European Commission to deliver the final word on its shot in December.
Elsewhere, Atara Biotherapeutics’ Ebvallo is poised to become the first allogeneic T-cell therapy approved worldwide following a positive opinion from EMA’s human medicines committee last month.
Premanufactured from unrelated donor cells, Ebvallo differs from current autologous T-cell therapies—such as Bristol Myers Squibb’s Abecma and Breyanzi and Gilead Sciences’ Yescarta and Tecartus—which are derived from a patient's own immune cells.
It hasn’t all been good news for drugmakers, though, with the EMA recently cracking down on certain medicines over safety concerns. Several weeks back, the regulator’s safety committee recommended limiting a group of oral JAK inhibitors use in certain at-risk patient groups unless no other suitable treatment alternatives are available. The safety decree covers AbbVie’s Rinvoq, Pfizer’s Cibinqo and Xeljanz, Eli Lilly’s Olumiant and Gilead’s Jyseleca.