The US Food and Drug Administration (FDA) recently issued significant updates affecting several pharmaceutical companies. These developments include a Complete Response Letter (CRL) to Aquestive Therapeutics regarding their drug application for dibutepinephrine (Anaphylm) Sublingual Film, alongside promising phase 2 results from Arcutis Biotherapeutics and other notable advancements in the sector.
FDA’s Complete Response Letter to Aquestive Therapeutics
On February 2, 2026, the FDA communicated its decision to Aquestive Therapeutics, issuing a CRL for the New Drug Application (NDA) concerning dibutepinephrine (Anaphylm) Sublingual Film. This product is intended for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg (approximately 66 pounds) or more. The FDA’s CRL, dated January 30, 2026, outlined deficiencies related to the human factors validation study. Issues included difficulties in opening the packaging and improper film placement, which could pose significant safety risks in emergency situations.
Positive Developments from Arcutis and Galderma
In contrast to the challenges faced by Aquestive Therapeutics, Arcutis Biotherapeutics announced positive topline results from its INTEGUMENT-INFANT phase 2 study on February 2, 2026. This study evaluated the safety and efficacy of roflumilast (Zoryve) cream 0.05% in infants aged 3 months to less than 24 months suffering from atopic dermatitis. Results indicated that the topical PDE4 inhibitor was well tolerated and consistently improved disease severity, with 58% of participants achieving a 75% reduction in the Eczema Area and Severity Index (EASI-75) by week four.
On the same day, Galderma announced that the FDA accepted its Biologics License Application (BLA) resubmission for RelabotulinumtoxinA, aimed at improving moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow’s feet) in adults. This advancement follows collaborative efforts to refine the manufacturing process, demonstrating the company’s commitment to meeting regulatory standards.
AbbVie and Pfizer’s Regulatory Submissions
On February 3, 2026, AbbVie revealed that it had submitted applications to both the FDA and the European Medicines Agency (EMA) for a new indication for upadacitinib (Rinvoq; 15 mg, once daily). This new application targets adult and adolescent patients diagnosed with non-segmental vitiligo. The submissions are backed by the Viti-Up studies, which assessed the drug’s safety and efficacy in this patient population.
Additionally, Pfizer reported positive topline results from the phase 2b VESPER-3 study on February 3, 2026. The study investigated the efficacy of its GLP-1 receptor agonist PF’3944 (MET-097i) in adults with obesity or overweight without type 2 diabetes. The results met the primary endpoint, demonstrating statistically significant weight loss at 28 weeks. Notably, weight loss continued even after transitioning from weekly to monthly dosing, suggesting a sustained efficacy without plateauing.
These developments reflect a dynamic landscape in the biopharmaceutical sector, where regulatory challenges and advancements coalesce to shape the future of healthcare. As new treatments emerge and existing applications undergo scrutiny, healthcare professionals remain at the forefront of navigating these changes, underscoring the importance of staying informed on key industry updates.
