The company said Friday that it had received FDA approval for Darzalex Faspro, a version of the intravenous Darzalex designed for faster administration and that carries a better toxicity profile.
The FDA approved Sarclisa, a CD38-targeting monoclonal antibody. The drug will face stiff competition from J&J's Darzalex, which has the same antigen target and is approved for the same population of patients.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The French drugmaker said the agency had accepted its application for isatuximab, a potential competitor to J&J's Darzalex. Positive Phase III data for isatuximab were presented at the ASCO meeting last month.
The company, whose FDA-approved products include the myeloma drug Darzalex and the chronic leukemia drug Arzerra, hopes to launch its own proprietary product by 2025.
A similar drug, Janssen's Darzalex, has already been on the market since 2014 and become well-established, with more than $1 billion in global sales last year.
Janssen halts lung cancer and myeloma trials, citing lack of clinical benefit and greater number of patient deaths in combo arm.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.