GlaxoSmithKline plc Sponsored ADR (GSK.US), Inovio (INO.US), and Agios (AGIO.US) are clustered in the queue awaiting review, as U.S. innovative drugs usher in an FDA approval window.

Last week, the U.S. Food and Drug Administration (FDA) approved a variety of new and expanded drug uses, the most notable being the approval of ImmunityBio's (IBRX.US) Anktiva for another type of bladder cancer. Now, all eyes are turning to the FDA's decisions on drugs for hepatitis B, respiratory diseases, and sickle cell disease. The momentum is set to continue in the coming weeks, with the FDA slated to rule on GlaxoSmithKline plc Sponsored ADR (GSK.US), Sun Pharmaceutical Industries, Inovio Pharmaceuticals (INO.US), and Agios Pharmaceuticals (AGIO.US). FDA Decision on GlaxoSmithKline plc Sponsored ADR's Hepatitis B Therapy The FDA is likely to announce its decision on GlaxoSmithKline plc Sponsored ADR's Bepirovirsen on October 26. This is an investigational drug for adults with chronic hepatitis B, designed to reduce the production of proteins that allow the virus to replicate and to help the immune system control the infection, potentially eliminating the need for continuous medication. The application is supported by the Phase 3 B-Well 1 and B-Well 2 trials. In these trials, 19% of eligible patients receiving Bepirovirsen plus standard of care achieved a functional cure, compared with none of those receiving standard of care alone. A functional cure means keeping the hepatitis B virus suppressed without treatment. Among patients with low viral activity at study entry, the functional cure rate was 26%. According to GlaxoSmithKline plc Sponsored ADR, the disease affects about 1.7 million people in the United States, and the FDA therefore granted the application Priority Review and Breakthrough Therapy designations. Inovio's RRP Therapy in Focus Next, investors' attention will turn to Inovio Pharmaceuticals. Its investigational drug INO-3107 for adults with recurrent respiratory papillomatosis (RRP) is expected to receive a regulatory decision on October 30. RRP is a rare disease caused by certain subtypes of human papillomavirus (HPV) that leads to recurrent growths in the respiratory tract. Patients often require repeated surgery to remove these growths. INO-3107 is designed to help the immune system attack HPV-infected cells. Inovio is seeking accelerated approval, and the disease is said to affect about 14,000 people in the United States. In a Phase 1/2 study of 32 patients, 81.3% of patients required fewer surgeries within one year after treatment, and 28.1% required no further surgery during or after treatment. Agios Awaits Approval Decision for Mitapivat Mitapivat was previously approved for certain inherited blood disorders, and Agios is now seeking accelerated approval for patients aged 16 and older with sickle cell disease. Sickle cell disease can cause anemia and potential organ damage. A decision is expected on November 1. The oral drug activates an enzyme called pyruvate kinase, helping red blood cells produce energy and function more effectively. Supporting the application is the Phase 3 Rise Up trial of 207 patients. The study showed that 40.6% of patients treated with Mitapivat achieved a meaningful increase in hemoglobin levels, compared with only 2.9% in the placebo group. Additional analyses also showed that patients treated with Mitapivat were less likely to require blood transfusions. Sun Pharma Seeks to Expand Ilumya's Indication India-based Sun Pharmaceutical Industries recently expanded its U.S. business through the acquisition of Organon (OGN.US). The company is awaiting the FDA's decision on Ilumya, an injectable drug being expanded for the treatment of active psoriatic arthritis. Ilumya works by blocking interleukin-23 (IL-23), a protein involved in inflammatory responses. The drug was first approved in the United States in 2018 for moderate-to-severe plaque psoriasis. Sun Pharma is seeking approval to expand Ilumya's use from skin symptoms to patients with joint-related disease, with a decision expected on October 29.