FDA Gears Up for October: Key Decisions on Novel Therapies Expected
Key Insights
Biofrontera's Ameluz seeks expanded dosage approval for actinic keratosis (search) treatment, potentially improving convenience for patients and dermatologists.
Bristol Myers Squibb (search) awaits FDA decision on Opdivo for perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (search).
Camurus (search)' Oclaiz, a long-acting Octreotide formulation, is under review for acromegaly (search), offering potential self-administration and higher bioavailability.
The FDA is poised to make several significant decisions in October regarding novel therapies for a range of conditions, from dermatological applications to cancer treatments and rare diseases. These decisions could have a notable impact on the treatment landscape and market competition.
Biofrontera Awaits Decision on Ameluz Dosage Increase
Biofrontera Inc. anticipates an FDA decision on October 4, 2024, regarding its request to increase the maximum approved dosage of Ameluz, a topical gel used in photodynamic therapy (PDT) for actinic keratosis (search), from one to three tubes per treatment session. Actinic keratosis, characterized by warty overgrowths of skin, affects many patients over large surface areas. The current recommendation limits application to 2 grams (one tube) over an area not exceeding 20cm2. The company believes that the ability to treat larger areas in a single visit would offer greater convenience for patients and improved efficiency for dermatologists.
Bristol Myers Squibb's Opdivo Under Review for NSCLC
Bristol Myers Squibb (search) (BMS) has applications under FDA review for Opdivo (nivolumab) in the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (search) (NSCLC). The applications cover neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo. The FDA decision is expected on October 8, 2024. NSCLC accounts for up to 84% of lung cancer diagnoses, and recurrence rates after surgery range from 30% to 55%. Opdivo is already approved for NSCLC as a monotherapy and in combination regimens. Approval in the perioperative setting would expand treatment options for patients.
Opdivo generated sales of $2.4 billion in the second quarter of 2024, compared to $2.1 billion in the year-ago quarter, highlighting its importance to BMS's portfolio.
Camurus Seeks Approval for Oclaiz in Acromegaly
Camurus (search) awaits an FDA decision on October 21, 2024, for Oclaiz, a once-monthly, subcutaneous (SC) long-acting depot formulation of Octreotide, for the treatment of acromegaly (search). Acromegaly is a rare, slowly progressive disease typically caused by a pituitary gland tumor that produces excess growth hormone, leading to elevated levels of insulin-like growth factor 1 (IGF-1). This results in abnormal growth of bones and tissues. Oclaiz is designed for easy self-administration, potentially via a pre-filled pen. Clinical trials have demonstrated approximately five-fold higher bioavailability compared to currently approved long-acting intramuscular Octreotide formulations, according to the company.
Lexicon Pharmaceuticals' Zynquista Faces AdCom for Type 1 Diabetes
Lexicon Pharmaceuticals Inc. has its drug candidate Zynquista under review as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (search) and chronic kidney disease. An FDA panel is scheduled to discuss the drug on October 31, 2024. Zynquista is an oral dual inhibitor of sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 (search) and SGLT2 (search)). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. This marks Zynquista's second attempt to gain FDA approval after an initial rejection in March 2019. The company resubmitted its New Drug Application in June 2024, with a final decision expected on December 20, 2024.