FDA Decisions Loom for Biofrontera, BMS, and Zealand Pharma
Key Insights
Biofrontera seeks FDA approval for a higher dose of Ameluz to treat actinic keratosis (search), potentially improving convenience for patients with large affected areas.
Bristol Myers Squibb (search) awaits a decision on Opdivo for perioperative treatment of resectable non-small cell lung cancer (search), based on Phase III data showing improved event-free survival.
Zealand Pharma anticipates FDA verdict on dasiglucagon for congenital hyperinsulinism (search), an ultra-rare genetic disease causing severe hypoglycemic episodes.
The FDA is poised to deliver decisions on supplemental applications and new drug candidates from Biofrontera, Bristol Myers Squibb (search) (BMS), and Zealand Pharma in early October.
Biofrontera Seeks Higher Dose for Actinic Keratosis Cream
Biofrontera anticipates an FDA decision by October 4 regarding its supplemental New Drug Application (sNDA) to increase the maximum dose of Ameluz (aminolevulinic acid HCl) to up to three tubes per treatment for actinic keratosis (search). Affecting over 58 million people in the U.S., actinic keratosis is a common precancerous skin condition caused by sun exposure. If untreated, it can evolve into squamous cell carcinoma.
Ameluz is a topical treatment administered with photodynamic therapy using a BF-RhodoLED lamp. The sNDA is supported by two Phase I trials demonstrating the safety of the higher dose. Data indicated that while blood levels of Ameluz's active ingredient and metabolites were transiently elevated, they remained well below levels associated with side effects. If approved, this dosing adjustment could allow doctors to treat larger areas in a single visit.
BMS Advances Opdivo for NSCLC
Bristol Myers Squibb (search) is seeking approval for Opdivo (nivolumab) in the perioperative treatment of resectable non-small cell lung cancer (search) (NSCLC), involving neoadjuvant PD-1 (search) treatment plus chemotherapy followed by postoperative adjuvant Opdivo. The FDA's decision is expected by October 8. The application is based on the Phase III CheckMate -77T study, which demonstrated a 42% reduction in the risk of disease recurrence, progression, or death with the Opdivo regimen. Participants in the Opdivo arm also achieved superior pathologic complete response and major pathologic response rates.
The FDA's Oncologic Drugs Advisory Committee has recently emphasized the need for improved trial designs in perioperative lung cancer studies to better differentiate the therapeutic contributions of each treatment phase.
Zealand Awaits Verdict for Rare Disease Therapy
Zealand Pharma awaits an FDA decision on dasiglucagon for treating congenital hyperinsulinism (search) (CHI), a rare genetic disease affecting 1 in 50,000 children. CHI is characterized by excessive insulin secretion, leading to frequent and severe hypoglycemic episodes that can cause seizures, brain damage, and death if untreated.
Dasiglucagon is an investigational glucagon receptor agonist designed to stimulate the release of stored sugar from the liver, counteracting insulin's glucose-lowering effects. Phase III data showed that dasiglucagon significantly reduced the need for intravenous glucose by 55% compared to placebo. The FDA previously approved dasiglucagon (marketed as Zegalogue) for severe hypoglycemia in diabetes. The CHI NDA is being reviewed in two parts, with the October 8 target action date pertaining to dosing for up to three weeks. A subsequent application for use beyond three weeks is expected by the end of 2024.