GSK (GSK.US), Inovio (INO.US), and Agios (AGIO.US) cluster for review, US innovative drugs welcome FDA approval window

Last week, the U.S. Food and Drug Administration (FDA) approved several new and expanded drug indications, with the most notable being the approval of ImmunityBio (IBRX.US)’s Anktiva for another type of bladder cancer. Now, all attention is turning to FDA decisions on drugs for treating hepatitis B, respiratory diseases, and sickle cell disease.

The momentum is set to continue in the coming weeks as the FDA will successively make decisions regarding GlaxoSmithKline (GSK.US), Sun Pharmaceutical Industries, Inovio Pharmaceuticals (INO.US), and Agios Pharmaceuticals (AGIO.US).

FDA Ruling on GlaxoSmithKline’s Hepatitis B Therapy

The FDA is likely to announce its decision on GlaxoSmithKline’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, with the potential to eliminate the need for ongoing medication.

The application is supported by the results of the Phase 3 B-Well 1 and B-Well 2 studies. In these trials, 19% of eligible patients who received Bepirovirsen combined with standard therapy achieved a functional cure, while none of those receiving standard therapy alone did. A functional cure means that the hepatitis B virus remains suppressed without the need for treatment.

Among patients with lower viral activity at the start of the study, the functional cure rate reached 26%.

According to GlaxoSmithKline, the disease affects about 1.7 million people in the U.S., which led the FDA to grant the application priority review status and breakthrough therapy designation.

Inovio’s RRP Therapy in the Spotlight

Next, investors’ attention will turn to Inovio Pharmaceuticals. Its investigational drug INO-3107 for adult recurrent respiratory papillomatosis (RRP) is expected to receive a regulatory decision on October 30.

RRP is a rare disease caused by specific subtypes of human papillomavirus (HPV), which results in repeated growths inside the respiratory tract. Patients often require repeated surgeries to remove these growths.

INO-3107 aims to help the immune system target cells infected with HPV. Inovio is seeking accelerated approval, and it is reported that the disease affects about 14,000 people in the U.S.

In a Phase 1/2 study involving 32 patients, 81.3% had fewer surgeries required within a year after treatment, and 28.1% did not require any more surgeries during or after treatment.

Agios Awaits Mitapivat Approval Decision

Mitapivat has already been approved for certain genetic blood disorders, and now Agios is seeking accelerated approval for patients aged 16 and older with sickle cell disease. Sickle cell disease can cause anemia and potentially organ damage. A decision on the approval is expected on November 1.

This oral medication activates an enzyme called pyruvate kinase, which helps red blood cells produce energy and function more effectively.

The application is supported by the Phase 3 Rise Up trial involving 207 patients. The study showed that 40.6% of patients treated with Mitapivat achieved a meaningful increase in hemoglobin levels, compared to just 2.9% in the placebo group.

Additional analyses also indicated that patients on Mitapivat were less likely to require blood transfusions.

Sun Pharma Seeks to Expand Ilumya Indication

India-based Sun Pharmaceutical Industries recently expanded its U.S. business by acquiring Organon (OGN.US). The company is awaiting an FDA decision on Ilumya, an injectable drug currently under review for expanded use in treating active psoriatic arthritis.

Ilumya works by blocking interleukin-23 (IL-23), a protein involved in inflammatory responses. The drug was first approved by the FDA in 2018 for treating moderate-to-severe plaque psoriasis.

Sun Pharma is seeking approval to expand Ilumya’s use from skin symptoms to joint-related diseases, with a decision expected on October 29.