Papzimeos Granted FDA Approval for Rare Respiratory Condition; Pfizer's Sickle Cell Drug Fails Trial, Lilly Teams Up with Superluminal Medicines for Cardiometabolic Diseases Treatment

The FDA granted full approval to Precigen's Papzimeos, a first-of-its-kind immunotherapy for recurrent respiratory papillomatosis. Pfizer's experimental sickle cell disease drug, inclacumab, failed to meet its goal in a Phase 3 study. Eli Lilly will collaborate with Superluminal Medicines to develop new drugs for cardiometabolic diseases and obesity.

The U.S. Food and Drug Administration (FDA) has granted full approval to Precigen's Papzimeos (zopapogene imadenovec-drba), marking a significant milestone in the treatment of recurrent respiratory papillomatosis (RRP). This approval signifies the first and only FDA-approved therapy for adults with RRP, addressing a long-standing unmet medical need [1].

Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against papilloma cells expressing HPV 6/11 proteins. The drug is delivered via four subcutaneous injections over a 12-week interval and has demonstrated efficacy in clinical trials, with 51% of study patients achieving a Complete Response and requiring no surgeries in the 12 months after treatment [1].

The approval of Papzimeos comes at a critical time, as RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic HPV 6 or HPV 11 infection. Management of RRP has traditionally relied on repeated surgeries, which do not address the root cause of the disease and can lead to significant morbidity and patient burden [1].

Precigen, a biopharmaceutical company specializing in innovative precision medicines, has been at the forefront of developing Papzimeos. The company's CEO, Helen Sabzevari, PhD, stated that the approval of Papzimeos represents a "historic turning point" for the RRP patient community [1].

In contrast to this positive development, Pfizer's experimental sickle cell disease drug, inclacumab, failed to meet its primary endpoint in a Phase 3 study, casting a shadow on the company's efforts in this therapeutic area [2].

Eli Lilly, another major pharmaceutical player, has announced a collaboration with Superluminal Medicines to develop new drugs for cardiometabolic diseases and obesity. This partnership aims to leverage Superluminal's expertise in small molecule drug discovery and Eli Lilly's extensive clinical and commercial capabilities [3].

The approval of Papzimeos by the FDA is a testament to the advancements in immunotherapy and the potential for innovative therapies to address previously intractable diseases. The drug's success in clinical trials and the positive response from the RRP community highlight the importance of continued investment in medical research and development.

References:
[1] https://www.morningstar.com/news/pr-newswire/20250815ny47895/precigen-announces-full-fda-approval-of-papzimeos-zopapogene-imadenovec-drba-the-first-and-only-approved-therapy-for-the-treatment-of-adults-with-recurrent-respiratory-papillomatosis
[2] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-negative-topline-phase-3-clinical-trial-results-for-inclacumab
[3] https://www.eli Lilly.com/newsroom/press-releases/2025/eli-lilly-and-superluminal-medicines-enter-collaboration-to-develop-new-drugs-for-cardiometabolic-diseases-and-obesity