As we progress into 2024, January saw only one novel drug receive approval from the FDA. This marks a significant reduction when compared to the four drugs that were approved during the same month in the previous year.
Currently, several biotech companies are awaiting feedback from the FDA regarding their proposed drug candidates throughout February.
One such firm is Ipsen, which is requesting FDA approval to broaden the use of its cancer medication, Onivyde, along with a chemotherapy combination known as NALIRIFOX. The duo is being proposed as an initial treatment for metastatic pancreatic ductal adenocarcinoma. A decision on this matter is expected to be made on February 13, 2024. Onivyde was initially granted approval in October 2015.
Another company vying for approval is Iovance Biotherapeutics. Its one-time tumor infiltrating lymphocyte (TIL) therapy, Lifileucel, is currently under FDA consideration, with a decision anticipated by February 24, 2024. Lifileucel is intended for patients who have displayed progress post-prior anti-PD-1/L1 therapy and targeted therapy in advanced melanoma cases. Should it be approved, Lifileucel will be the sole TIL therapy for this patient cohort.
Likewise, Alvotech's AVT02, a biosimilar to AbbVie's Humira, is another drug candidate presently under FDA scrutiny. The verdict is set to be released on February 24, 2024. Approval of AVT02 would make it the first interchangeable high-concentration biosimilar to Humira in the U.S.
Lastly, Minerva Neurosciences is awaiting an FDA review regarding its New Drug Application for Roluperidone as a treatment for the negative symptoms of schizophrenia. The decision is projected to be given by February 26, 2024. Schizophrenia, which currently affects around 20 million people globally, is a severe mental health disorder characterized by disruptive thoughts, perceptions, and emotions. If authorized, Rolluperidone will serve as the first drug treatment for negative symptoms of schizophrenia in the U.S.
