First Sildenafil Film Gains FDA Approval for Erectile Dysfunction
On Feb. 5, 2026, the US Food and Drug Administration (FDA) approved IBSA USA’s Vybrique™ (sildenafil), a phosphodiesterase-5 (PDE5) inhibitor and the first oral film for treating erectile dysfunction (ED) in men aged 18 years and older. The single‑dose film uses FilmTec® technology to dissolve on the tongue without water and can be taken thirty minutes to four hours before sexual activity, with or without food. Approval was based on a 12‑week, randomized, double‑blind, placebo‑controlled trial that demonstrated statistically significant improvements in ED across 25mg, 50mg, 75mg, and 100mg dosing levels. The recommended dosing follows traditional sildenafil parameters with flexibility based on clinical response. Similar to the other PDE5 inhibitors, Vybrique should not be used by men who also take nitrates, commonly used to treat chest pain (angina), because the combination can cause a sudden drop in blood pressure. Launch is expected in March 2026. The prescribing information is here.
Label Update for Yescarta Expands Population
The FDA approved a label update for Kite, a Gilead Company’s Yescarta® (axicabtagene ciloleucel) on Feb. 6, 2026. The FDA removed the prior Limitation of Use for patients who have relapsed or refractory primary central nervous system lymphoma (PCNSL), a rare and aggressive form of non‑Hodgkin lymphoma. Yescarta originally carried a Limitation of Use for PCNSL because patients with primary or secondary CNS involvement were excluded from the pivotal trials, driven by concerns that chimeric antigen receptor (CAR) T-cell therapy-associated neurologic toxicities could be more severe or difficult to manage in patients with active CNS disease and by the lack of prospective safety data demonstrating acceptable risk in this population. Removal of the limitation of use was supported by results from a phase I investigator‑sponsored study conducted at Dana‑Farber Cancer Institute, in which neurologic toxicities were observed in 85% of patients (11/13) and no new safety signals were identified. Administered only by specially trained health professionals and only in health facilities certified to administer it, Yescarta is produced by collecting and then altering some of the patient’s T cells so that they bind specifically to CD19, an antigen generated by B cells. Processing takes about three weeks. When the modified CAR-T cells are infused back into the patient, they inactivate CD19, destroying the cancerous B cells that produce it. After three days of pretreatment with chemotherapy (chemo), Yescarta is administered as a one‑time intravenous (IV) infusion. Here is the updated prescribing information.