In a flurry of activity, Europe’s human medicines committee has done an about-face on Eisai and Biogen’s Alzheimer’s disease med Leqembi, endorsed a clutch of biosimilars, recommended a slew of label expansions and put forward new cancer and COVID drugs for approval.
Overall, the European Medicines Agency’s (EMA's) Committee for Medicinal Products for Human Use (CHMP) signed off on four new drugs along with as many biosimilars and recommended 11 label expansions this week, according to an agency roundup issued Friday.
At the same time, CHMP urged against green lights for two drugs: Legacy Healthcare’s Cinainu (allium/citrus/paullinia/cacao) for moderate to severe alopecia areata and Orphelia Pharma’s Kizfizo (temozolomide) in the rare cancer neuroblastoma.
On the oncology front, the CHMP gave a thumbs-up to Bristol Myers Squibb’s next-gen tyrosine kinase inhibitor (TKI) repotrectinib, also known as Augtyro, in adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). The recommendation also covers adults and kids ages 12 and older with advanced solid tumors expressing an NTRK gene fusion who’ve either received a prior NTRK inhibitor or for whom non-NTRK-targeting therapies are insufficient.
The endorsement tees up BMS’ drug—which was approved by the FDA in June—for a potential approval from the European Commission (EC) in January, Bristol said in a release.
Meanwhile, the human medicines committee also backed Johnson & Johnson’s TKI Lazcluze (lazertinib) in combination with the company’s bispecific antibody Rybrevant for first-line treatment of adults with advanced NSCLC. The J&J combo snared approval for a similar indication in the U.S. back in August.
Separately, the CHMP has recommended InflaRx’s Gohibic (vilobelimab) for a marketing authorization under exceptional circumstances to treat adults on corticosteroids and invasive mechanical ventilation with SARS-CoV-2-induced acute respiratory distress syndrome. In a press release, InflaRx said it expects the EC to issue a formal approval verdict within 67 days from Friday, which would place the decision sometime in late January.
The company added that it’s considering marketing distribution options with potential partners in the EU.
Beyond new drugs, the agency also supported European green lights for Klinge Biopharma’s biosimilar Baiama (aflibercept) and its duplicate Ahzantive, which mimic Bayer and Regeneron’s Eylea for the treatment of age-related macular degeneration and visual impairment from macular edema secondary to retinal vein occlusion, diabetic macular edema or myopic choroidal neovascularization.
Samsung Bioepis’ biologic copycats Obodence and Xbryk, referencing Amgen’s bone drugs Prolia and Xgeva, respectively, also won endorsements from the European drug regulator.
As for existing medicines, the CHMP put its chips behind label expansions for drugs from Sanofi, Regeneron, Merck & Co., Incyte and others.
Perhaps most notably, Merck’s immune-oncology stalwart Keytruda—in combination with pemetrexed and platinum chemotherapy—won the agency’s backing for first-line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma. Merck expects the EC to issue its final decision on the potential label expansion in 2024’s fourth quarter.
Also of note, Sanofi’s Sarclisa plus bortezomib, lenalidomide and dexamethasone (VRd) scored an approval vote from CHMP in adults with newly diagnosed multiple myeloma who aren’t eligible for autologous stem cell transplant, teeing up a formal decision from the EC “in the coming months,” Sanofi said Thursday.
With Europe’s human medicines committee now onboard, all drugs endorsed this week must now go before the EC for a final decision on approval.
Elsewhere, in a decision made earlier this week, the EMA made a significant reversal when it voiced favor around a green light for Biogen and Eisai’s amyloid-busting antibody Leqembi.
After rejecting the drug in July, the agency’s drug regulators pushed the medicine forward for approval to treat mild cognitive impairment or mild dementia caused by Alzheimer’s, but only in patients who have one or no copy of the ApoE4 gene.
Patients with two copies of the gene are at higher risk of experience side effects of brain swelling or bleeding, collectively known as amyloid-related imaging abnormalities (ARIA).
In making its reexamination, the CHMP weighed subgroup analyses from Eisai showing that 8.9% and 12.9% of patients in the drug’s restricted population experienced ARIA brain swelling or bleeding, respectively, versus 12.6% and 16.9% in the overall population.
The agency also took into account submissions from patients, caregivers, clinicians and organizations who voiced their opinions on the unmet need in patients with Alzheimer’s.