News|Articles|October 30, 2026

October FDA Approvals Bring Advances Across 5 Specialties

October's FDA approvals included the introduction of 5 non-oncology treatment options across specialties.

October's FDA approvals brought notable advances beyond oncology, adding new treatment options in allergy and immunology, psychiatry, ophthalmology, hepatology, and gastroenterology. They include first-in-class treatments, at-home options, and more.

Here are 5 FDA approvals from the past month outside the oncology space:

FDA Approves First Symptomatic Dermographism Treatment

To start the month, the FDA approved remibrutinib (Rhapsido; Novartis) as the first treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines on October 7, making the oral, highly selective Bruton tyrosine kinase inhibitor the only prescription treatment with approved uses in both chronic spontaneous urticaria (CSU) and SD.¹

The decision was based on data from the SD cohort of the phase 3 RemIND trial (NCT05976243), where investigators analyzed patients who remained symptomatic despite treatment with second-generation H1 antihistamines. Using the Total Fric Score, they found that remibrutinib showed higher rates of complete response for hives than placebo.

At week 12, significantly more patients treated with remibrutinib achieved a complete response from hives vs placebo (29.35% vs 14.0%; P = .0229), with responses seen as early as week 2. Through week 24, remibrutinib demonstrated a consistent safety profile in both SD and CSU, with the most common adverse events including nasal congestion, sore throat, runny nose, bleeding, headache, nausea, and abdominal pain.

“Remibrutinib offers, for the first time, an approach to treatment specifically for SD patients who remain inadequately controlled with H1 antihistamines alone, representing a meaningful step forward for this population,” Giselle Mosnaim, MD, MS, lead RemIND trial investigator, clinical professor at the University of Chicago Pritzker School of Medicine, and allergist and immunologist at Endeavor Health, said in a news release.²

FDA Approves Once-Monthly Subcutaneous Olanzapine for Schizophrenia

Two days later, on October 9, the agency approved an olanzapine extended-release injectable suspension (Weltruza; Teva Pharmaceuticals), a once-monthly subcutaneous (SC) long-acting injectable for the treatment of schizophrenia in adults.³SC olanzapine will be available in 318, 425, and 531 mg once-monthly doses, corresponding to the approved daily oral olanzapine doses of 10, 15, and 20 mg, respectively.

This decision makes it the first and only once-monthly SC injectable formulation of olanzapine, requiring no loading doses, oral supplementation, or post-injection monitoring. It was based on the phase 3 SOLARIS trial (NCT05693935), a multinational, randomized, double-blind, placebo-controlled study of adults aged 18 to 64 years with schizophrenia.

During the first 8 weeks, 675 patients with acute exacerbation of schizophrenia were randomized 1:1:1:1 to low-, medium-, or high-dose SC olanzapine or placebo. Afterward, in the next 48 weeks, patients who received placebo were rerandomized equally to 1 of the 3 SC olanzapine doses, and those who received the treatment stayed on their established dose.

The primary objective was efficacy as measured by the Positive and Negative Syndrome Scale (PANSS). All 3 doses produced significantly greater improvement in the PANSS total score than placebo from baseline to week 8, with differences of -9.75 (95% CI, –13.60 to –5.89), –11.27 (95% CI, –15.01 to –7.53), and –9.76 (95% CI, –13.50 to –6.02), respectively.

Regarding safety, all 3 doses were similarly tolerated. The most common adverse events included increased weight, headache, constipation, and injection site reactions.

FDA Approves First At-Home SC Thyroid Eye Disease Treatment

On October 15, the FDA approved satralizumab-mwge (Enspryng; Genentech) for adults with thyroid eye disease (TED), making it the first and only at-home SC option for these patients.⁴ This was based on data from the phase 3 SatraGO program, SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828), which evaluated the efficacy, durability, and tolerability of satralizumab in adults with active, moderate-to-severe TED and chronic TED.

The primary end point for both trials was the proportion of participants with active, moderate-to-severe TED who achieved a reduction in proptosis of at least 2 mm in the study eye from baseline at week 24. Although SatraGO-1 did not meet this end point, the active TED population in SatraGO-2 demonstrated significant and clinically meaningful improvements in both proptosis response (52.9% vs 23.4% in the satralizumab vs placebo groups, respectively) and diplopia reduction (60.7% vs 25.8%). Consistent findings were observed in the overall SatraGO-2 population, which included both patients with active and chronic TED.

No new safety signals were identified in the SatraGO trials. The most commonly observed adverse effects were nasopharyngitis, headache, upper respiratory tract infection, rash, joint pain, extremity pain, fatigue, nausea, and inflammation of the lining of the stomach.

“The availability of an effective [SC] treatment option could provide greater flexibility for both patients and physicians while reducing the logistical burden associated with infusion-based therapies,” César A. Briceño, MD, clinical trial investigator and associate professor of ophthalmology at the Scheie Eye Institute, University of Pennsylvania, said in a news release.⁵ “Enspryng has the potential to meaningfully expand our therapeutic options for patients with [TED].”

Bepirovirsen Approval Offers New Option for Chronic HBV Treatment

Less than a week later, on October 20, the agency approved bepirovirsen (Hibsago; GSK) injection in combination with existing antiviral therapy to treat a subset of patients with chronic hepatitis B virus (HBV) infection without cirrhosis, making it the first antisense oligonucleotide approved for this indication.⁶

Specifically, the treatment is indicated for patients without cirrhosis who have received HBV antiviral therapy for at least 6 months, have suppressed HBV levels in their blood, and have hepatitis B surface antigen (HBsAg) levels of 3000 IU/mL or less. It targets the genetic instructions HBV uses to replicate and produce viral proteins, helping reduce the amount of virus and HBsAg in the body. In addition, the FDA authorized the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic device to help identify eligible patients with chronic HBV infection and to support monitoring throughout treatment.

Results from the B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820) phase 3 trials supported the decision. Both trials met their primary end points, demonstrating statistically significant improvements in functional cure vs placebo in the overall study population of adults with HBsAg levels of 3000 IU/mL or less.

They also demonstrated an acceptable safety and tolerability profile, with the most common adverse events reported including injection site erythema, local pain, and a temporary increase in blood levels of a liver enzyme.

Mark Makhinson, PharmD, senior director of outpatient and specialty pharmacy at Mount Sinai Health System, emphasized the treatment’s potential in a recent interview with The American Journal of Managed Care^®(AJMC^®).

“I think this is a revolutionary drug that’s going to change the paradigm of care for patients [with HBV],” he told AJMC. “This is the first cure in the space instead of a lifelong treatment. So, taking patients off continuous antiviral therapy and shifting them to a cure-based treatment is really going to impact the paradigm of care…I’m hopeful that we see a functional cure in a large proportion of patients in this population.”

FDA Approves At-Home SC Induction for Risankizumab in Crohn Disease

Rounding out the month, the FDA approved an SC induction regimen for risankizumab-rzaa (Skyrizi; AbbVie) in adults with moderately to severely active Crohn disease on October 23, giving patients the option to begin therapy at home with an on-body injector (OBI) instead of traveling to an infusion center.⁷ With this treatment, patients receive 720 mg of risankizumab via an OBI induction pack at weeks 0, 2, 4, and 8, then continue maintenance dosing with the OBI every 8 weeks starting at week 12.

The approval was based on the phase 3 AFFIRM trial (NCT06063967), in which 274 adults were randomized 2:1 to SC risankizumab or placebo. At week 12, SC risankizumab met both coprimary end points; clinical remission, defined as a Crohn’s Disease Activity Index score below 150, was achieved by 56% of patients vs 30% with placebo, and endoscopic response by 43% vs 15% (P < .001 for both). Longer-term data showed that 35.8% of patients receiving SC risankizumab achieved endoscopic remission at week 24 vs 9.1% with placebo, and 36.6% of those with ulcers at baseline achieved ulcer-free endoscopy vs 9.1%.

The investigators did not identify any new safety signals through week 24. Therefore, SC induction was consistent with risankizumab’s known safety profile in Crohn disease.

“As a physician who has used the Skyrizi OBI, I’ve seen firsthand the convenience it can offer patients,” Millie D. Long, MD, MPH, chief of the division of gastroenterology and hepatology at the University of North Carolina at Chapel Hill and lead investigator of the AFFIRM trial, said in a news release.⁸ “Now with this approval, patients can start treatment at home and continue the same way through maintenance.”

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