GlaxoSmithKline (GSK.US), Inovio (INO.US), and Agios (AGIO.US) are all awaiting review, and US stocks of innovative drugs welcome FDA approval window

Last week, the US Food and Drug Administration (FDA) approved a number of new and expanded drug uses, the most notable of which was ImmunityBio (IBRX.US)'s Anktiva approved for another type of bladder cancer. All eyes are now on the FDA's decisions on drugs to treat hepatitis B, respiratory disease, and sickle cell disease.

In the next few weeks, this trend will continue, and the FDA will successively rule on GlaxoSmithKline (GSK.US), Sun Pharmaceutical Industries, Inovio Pharmaceuticals (INO.US), and Agios Pharmaceuticals (AGIO.US).

FDA ruling on GlaxoSmithKline Hepatitis B treatment

The FDA is likely to announce its decision on GlaxoSmithKline's Bepirovirsen on October 26. It is a drug under development for chronic hepatitis B in adults. It aims to reduce the production of proteins that allow the virus to replicate and help the immune system control the infection. It is expected that there is no need for continuous medication.

The application was supported by Phase 3 B-Well 1 and B-Well 2 trials. In these trials, 19% of eligible patients receiving standard treatment with Bepirovirsen achieved functional cure, while none of those receiving standard treatment alone achieved it. Functional cure means that the hepatitis B virus remains suppressed without treatment.

Among patients with low viral activity at the beginning of the study, the functional cure rate was 26%.

According to GlaxoSmithKline, the disease affects approximately 1.7 million people in the US, so the FDA granted priority review and breakthrough therapy status to the application.

Inovio's RRP treatment takes center stage

Investors' eyes will then be on Inovio Pharmaceuticals. Its ongoing drug for recurrent respiratory papillomatosis (RRP) in adults, INO-3107, is expected to receive a regulatory decision on October 30.

RRP is a rare disease caused by a specific subtype of human papillomavirus (HPV), which causes recurrent growth of tumors in the respiratory tract. Patients often require repeated surgeries to remove these neoplasms.

INO-3107 is designed to help the immune system attack HPV-infected cells. Inovio is seeking accelerated approval, and the disease allegedly affects approximately 1.4 million people in the US.

In a phase 1/2 study involving 32 patients, 81.3% of patients needed fewer surgeries within one year of treatment, and 28.1% of patients did not need surgery during or after treatment.

Agios awaits Mitapivat's approval decision

Mitapivat has previously been approved for certain hereditary blood diseases, and now Agios is seeking accelerated approval for patients with sickle cell disease aged 16 and above. Sickle cell disease can lead to anemia and potential organ damage. The approval decision is expected to be announced on November 1.

This oral medication activates an enzyme called pyruvate kinase to help red blood cells produce energy and function more effectively.

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

Additional analysis also showed that patients treated with Mitapivat were less likely to need a blood transfusion.

Sun Pharmaceuticals wants to expand Ilumya's indications

Sun Pharmaceutical Industries, headquartered in India, recently expanded its US business through the acquisition of Organon (OGN.US). The company is awaiting a FDA decision on Ilumya, and the injectable drug is being expanded to treat active psoriatic arthritis.

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

Sun Pharmaceuticals is seeking approval to extend the use of Ilumya from skin symptoms to patients with joint-related diseases, and the approval decision is expected to be announced on October 29.