News briefing: Novartis eyes expansion for Eylea rival with PhIII results; Dupixent obtains BTD for EoE
Novartis reported positive topline results in a Phase III for its Eylea rival, a sign that the company is pushing the brolucizumab compound, approved last October in the US, for a potential label expansion.
Brolucizumab, sold as Beovu, is now being studied in diabetic macular edema. Novartis said the 6 mg dose met its primary endpoint of non-inferiority to 2 mg of Eylea in mean change in best-corrected visual acuity (BCVA) after one year.
The trial also met key secondary endpoints, with Novartis claiming superior improvement against Eylea in change of central subfield thickness and that more than half of brolucizumab patients maintained a three-month dosing interval through the first year, following the loading phase.
Beovu received the FDA thumbs up in October 2019 for the treatment of wet age-related macular degeneration. This past June, following concerns over rare post-marketing events of vasculitis and retinal occlusive vasculitis, regulators updated the label to include safety information regarding the conditions.
Dupixent inches closer to eosinophilic esophagitis indication
Sanofi and Regeneron’s blockbuster Dupixent has obtained a breakthrough therapy designation for a new indication, the companies said Monday.
Regulators handed down the decision for Dupixent to treat eosinophilic esophagitis in patients 12 years and older. This comes following the results from the first part of a Phase III trial, which showed a reduction in symptoms, esophageal inflammation and abnormal endoscopic findings in the esophagus for patients.
Dupixent is already approved in several indications, including atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis. Over the first six months of 2020, Dupixent has pulled in nearly $2 billion in global sales.
The drug would have almost no competition in the EoE field, a condition that is generally treated with diet, steroids and acid suppressors. Two parts of the Phase III trial remain, including different dosing levels and extended treatment.
Evotec to build infectious disease hub with Bioaster Technology Research Institute
German-based Evotec and French-based Bioaster have partnered up to build a new infectious disease hub in Lyon, France.
The new collaboration agreement will advance new research projects against infectious diseases and antimicrobial resistance, potentially creating new therapies and technologies, the organizations said Monday. Financial terms of the deal were not disclosed. Evotec and Bioaster have been working together since the beginning of 2020, and Evotec will be the first R&D company to locate staff in Bioaster premises in Lyon.
With more than 120 researchers in total, the companies will share the same advanced infrastructures, including five BSL3 laboratories and easy access to diverse equipment. The ultimate goal is to meet the expectations of the industry to accelerate and de-risk their product developments in infectious diseases.
Monday’s collaboration comes less than a month after Evotec teamed up with Novo Nordisk to target CKD, a deal in which the German biotech can earn up to $179 million per project.