Faricimab

Roche reported strong Q3 and nine-month results, with sales up 9% at constant exchange rates. Sanofi is in exclusive talks with CD&R to sell a controlling stake in its consumer healthcare business, Opella. The FDA approved Pfizer’s RSV vaccine, Abrysvo, for adults under 60. Novo Nordisk’s cardiovascular outcomes study on oral semaglutide met its primary endpoint, and AstraZeneca’s Wainzua received a positive CHMP recommendation for EU approval.

Amgen plans to launch its biosimilar of Regeneron's Eylea in the US despite ongoing patent infringement litigation, with potential risks and rewards. The US Court of Appeals lifted a temporary injunction, prompting Amgen's decision. Regeneron maintains Amgen's infringement belief and appeals process continues, with oral arguments set for January. Eylea, approved for various eye diseases, faces competition from Roche's Vabysmo.

A matching-adjusted meta-analysis presented at the AAO 2024 compared Eylea HD and Vabysmo, revealing Vabysmo provided higher CST reduction in DME and nAMD patients, with CST thinning by 19µm more than Eylea and Eylea HD.

Roche reports 6% Group sales growth at constant exchange rates, driven by high demand for medicines and diagnostics. Pharmaceuticals Division sales rose 7%, with strong growth in base business, led by Vabysmo, Phesgo, and Ocrevus. Diagnostics Division sales increased 5%, with base business growing 8%. Key developments include US and EU approvals for new treatments, positive phase III data, and acquisitions to strengthen pipelines. Outlook for 2024 is confirmed.

Roche's Vabysmo therapy for diabetic macular edema (DME) shows consistent efficacy in African American, Black, Hispanic, and Latino patients, as demonstrated by the ELEVATUM trial. The study, conducted at diverse sites, revealed similar improvements in vision to those seen in predominantly White populations, addressing underrepresentation in clinical trials.

In an interview, Dr. Jeremiah Brown discusses the ELEVATUM study, which allows patients to self-identify as Black, Hispanic, or Native American, and collects data on socioeconomic status, ZIP codes, education, BMI, and genetics. Results from the study, presented at the American Academy of Ophthalmology meeting, showed consistent outcomes with previous trials of Vabysmo among 124 participants.

The ELEVATUM study, led by Dr. Jeremiah Brown, aimed to address underrepresentation in ophthalmology trials, particularly for Black, Hispanic, and other groups. The study, involving 124 participants, showed consistent results with the YOSEMITE and RHINE studies of Vabysmo for diabetic macular edema treatment.

Roche's ELEVATUM study showed faricimab (Vabysmo) improved vision in DME patients from underrepresented racial and ethnic groups, with Hispanic and Latino participants achieving an average gain of 14.1 letters and African American and Black participants gaining 11.3 letters after one year of treatment every eight weeks. The study, the first retina trial for these populations, aligns with previous data and aims to improve care for these communities.

Roche's ELEVATUM study showed Vabysmo (faricimab) effectively treats diabetic macular edema (DME) in underrepresented racial and ethnic groups, improving vision by 12.3 letters on average. Hispanic and Latino participants, starting with the most severe disease, gained 14.1 letters, while African American and Black participants gained 11.3 letters. Vabysmo was well-tolerated, with no new safety events. The study, presented at AAO 2024, is the first retina trial for these populations.