Lecanemab

The European Medicines Agency’s human medicines committee handed down a slew of positive recommendations for drugs on Friday, including Merck’s blockbuster cancer drug Keytruda and InflaRx’s monoclonal antibody Gohibic for Covid-19. The committee recommended label expansions for 11 drugs, including the Keytruda-pemetrexed-platinum chemotherapy combination for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma, and Bristol Meyers Squibb’s Opdivo-Yervoy combination for the first-line treatment of a type of unresectable or metastatic colorectal cancer. Eight new medicines were recommended for approval, including a marketing authorization under exceptional circumstances for Gohibic for the treatment of SARS‑CoV2‑induced acute respiratory distress syndrome. The FDA granted it an emergency use authorization last year. InflaRx noted in a statement that the exceptional circumstances recommendation means that the benefit-risk assessment of the drug is positive — but “due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use.” InflaRx added that approval in the EU is expected early next year and that it’s considering potential partnerships for commercial distribution. Bristol Myers’ oral tyrosine kinase inhibitor, Augtyro, won a conditional marketing authorization recommendation for advanced solid tumors and locally advanced or metastatic non-small cell lung cancer. Four biosimilars were also recommended, including: Formycon’s Baiama and Klinge Biopharma’s Ahzantive as biosimilars to Eylea for several forms of macular degeneration and other eye diseases; Samsung Bioepis’ denosumab biosimilars Obodence for osteoporosis and bone loss, and Xbryk for the prevention of issues like fractures in adults with bone tumors. Samsung Bioepis touted the recommendations, noting that if the European Commission authorizes the drugs, they would be Samsung Bioepis’ first endocrinology biosimilars approved in Europe. The committee also rejected two drugs: Legacy Healthcare’s Cinainu for the treatment of alopecia areata, a disease that causes hair loss, and Orphelia Pharma’s Kizfizo for the treatment of neuroblastoma. These decisions come on the heels of the committee reversing course and deciding in favor of Eisai and Biogen’s Alzheimer’s treatment Leqembi on Thursday for the treatment of a subset of early-stage Alzheimer’s patients who have one or no copies of a form of a gene called APOE4. That gene can make it more likely that a patient experiences brain imaging abnormalities known as ARIA, an adverse event linked with Leqembi. The committee originally recommended against Leqembi in a broader Alzheimer’s population over the summer.