FDA Roundup: Soliris Biosimilar, Nonerosive GERD Treatment

FDA Approval Marks Epysqli as Second Soliris Biosimilar

FDA Roundup: Soliris Biosimilar, Nonerosive GERD Treatment / Grandbrothers - stock.adobe.com

The FDA approved eculizumab-aagh (Epysqli) as a biosimilar to eculizumab (Soliris). The biosimilar has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

The approval was supported by a totality of evidence from a randomized phase 1, double-blind, 3-arm, parallel group, clinical single trial of healthy volunteers (NCT03722329) and a randomized phase 3, double-blind, multicenter, cross-over study in patients with PNH (NCT04058158). The studies showed pharmacokinetics equivalence and comparable pharmacodynamic safety, tolerability, and immunogenicity profiles between eculizumab-aagh and eculizumab and clinical equivalence in efficacy, safety, pharmacokinetics, and immunogenicity between eculizumab-aagh and eculizumab, respectively.

The approval of eculizumab-aagh marks Samsung Biopepis’ 8th biosimilar approved by the FDA and the second biosimilar approved for eculizumab. The first, eculizumab-aeeb, received FDA approval in May 2024.

With FDA Approval, Vonoprozan Offers Options for Nonerosive GERD

The FDA approved vonoprazan (Voquenza) 10 mg tablets for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults.This represents the third FDA approval for vonoprazan; the drug is also approved to treat erosive esophagitis or erosive GERD and Helicobacter pylori infection, in combination with antibiotics.

Approval was based on positive results from the PHALCON-NERD-301 study (NCT05195528), a phase 3, randomized, placebo-controlled, double-blind, multicenter, US-based study evaluating the efficacy and safety of daily vonoprazan therapy in a cohort of 772 adults who experienced 4 or more days of heartburn per week. Patients received vonoprozan 10 mg daily, and outcomes were compared with placebo with an outcome measure of heartburn relief over 4 weeks. During a 20-week extension period, investigators evaluated vonoprazan for long-term treatment.

Results of PHALCON-NERD-301 were positive: Vonoprazan demonstrated quick and significant reduction in heartburn through week 4, including all-day, all-night heartburn relief, “with significantly more 24-hour heartburn-free days through week 4” vs placebo. Mean percentage of heartburn-free days in the treatment group was 45% (vs 28% in placebo), with a median of 48% of 24-hour heartburn-free days (vs 17% in placebo). Study results were presented earlier this year at Digestive Disease Week 2024 and were published in Clinical Gastroenterology and Hepatology.

FDA, FTC Issue Warnings to Companies Selling Copycat Food Products Containing Delta-8 THC

The FDA send warning letters to 5 companies illegally selling copycat food items containing delta-8 THC, in violation of the Federal Food, Drug, and Cosmetic Act. These letters are part of a joint effort from the FDA and the Federal Trade Commission (FTC) “to take action against companies selling illegal copycat food products containing delta-8 THC,” per an FDA news release. The agencies previously worked together in June 2023 to distribute warning letters for 6 other companies selling edible food products containing delta-8 THC “in packaging that could easily be confused for foods sold by popular national brands.”

Between January 1, 2021, and December 31, 2023, the FDA received more than 300 reports of adverse events involving both children and adults who consumed delta-8 THC–containing products—nearly half of which involved emergency department visits or hospitalizations. Approximately two-thirds of these adverse events were related to ingestion of delta-8 THC products such as candy or brownies, and included hallucinations, vomiting, tremor, anxiety, dizziness, confusion, and loss of consciousness, among others.

READ MORE: Biosimilars Resource Center

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