Roche's fast-growing eye drug Vabysmo set for EU approval

Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer's mighty Eylea in the US – and could soon start making inroads against its rival in Europe.

Vabysmo (faricimab) has been recommended by the EMA's human medicines committee as a treatment for neovascular or wet age-related macular degeneration (AMD) and diabetic macular oedema (DME), so could be fully approved and ready to roll out in the next few months, subject to pricing and reimbursement negotiations.

The bispecific antibody binds to VEGF – the same target as $8 billion-a-year blockbuster Eylea (aflibercept) – as well as a second target Ang-2, tackling two disease pathways associated with the sight-robbing diseases.

Vabysmo was only approved in the US in January but already seems to have made great headway in the market, with Roche reporting second quarter sales of around $112 million and more than 70,000 vials distributed in the first five months since its debut.

Worryingly for Bayer and Regeneron, the pharma group says Vabysmo's strong uptake is being driven in part by switching "primarily from aflibercept" as it chases market share in a global retinal diseases market valued at around $15 billion.

Vabysmo still has a mountain to climb to catch Eylea, but Roche continues to build the clinical case for its drug reporting two-year results with the drug in wet AMD earlier this month which suggested it continued to be effective whilst cutting the number of injections into the eye needed by patients.

Over the two-year period, patients received 10 injections with the bispecific antibody, compared to 15 with Regeneron and Byer's drug.

"With the potential to require fewer injections over time while also improving and maintaining vision, Vabysmo could offer a less burdensome treatment schedule for patients, their caregivers, and healthcare systems," said Roche's chief medical officer Levi Garraway after the CHMP recommendation.

July meeting highlights

The latest meeting of the CHMP results in 11 new medicines being recommended for approval in the EU, including:

- Bristol-Myers Squibb's Opdualag (relatlimab/nivolumab) for advanced melanoma, which if approved will be the first drug in Europe to include a drug targeting the LAG-3 immune checkpoint. The combination was cleared by the FDA in March;

- Alynlam's Amvuttra (vutrisiran) for adults with hereditary transthyretin-mediated amyloidosis (hATTR), a month after the drug was approved in the US. It offers a simpler, more patient-friendly dosing regimen than Alnylam's earlier drug Onpattro (patisiran) for this indication;

- AstraZeneca's first-in-class TSLP inhibitor Tezspire (tezepelumab) as an add-on therapy for adolescents and adults with severe asthma;

- Johnson & Johnson's CD3xBCMA bispecific antibody Tecvayli (teclistamab) for relapsed and refractory multiple myeloma (see our article here);

- Eli Lilly's dual GLP-1 and GIP agonist Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes mellitus, which was approved by the FDA in May and has been billed as a potential $3 billion-a-year blockbuster;

- Aurinia Pharmaceuticals and Otsuka' oral calcineurin inhibitor Lupkynis (voclosporin) for the treatment of lupus nephritis, a complication of the autoimmune disease system lupus erythematosus (SLE);

- Comharsa Life Sciences' Nulibry (fosdenopterin) for the treatment of molybdenum cofactor deficiency type A;

- Billev Pharma's Illuzyce (lutetium [177lu] chloride for radiolabelling of carrier medicines that have been developed and authorised for radiolabelling with lutetium chloride;

- YES Pharma's Celdoxome, a pegylated liposomal formulation of the chemotherapeutic drug doxorubicin hydrochloride intended for the treatment of metastatic breast cancer, advanced ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma; and

- Lipomed's hybrid medicine Thalidomide Lipomed (thalidomide) for the treatment of multiple myeloma. Hybrid medicines rely in part on the results of preclinical tests and clinical trials of an already authorised reference product and in part on new data.