Peptide News Digest

Amneal Generic Lanreotide FDA Approval, Novo Denecimig CHMP for Hemophilia A, Lilly Inluriyo+Verzenio ESR1 Breast Cancer

Amneal generic lanreotide FDA approval + immediate launch, Novo denecimig CHMP for hemophilia A, Lilly Inluriyo+Verzenio FDA approval for ESR1-mutated BC.

4 stories · Covering regulatory

Editor's Note

Sunday's digest collects four regulatory decisions from late in the week. Amneal Pharmaceuticals won FDA approval for a lanreotide 120 mg injection referencing Somatuline Depot, which IQVIA data put at $983 million in U.S. sales for the 12 months ended July 2026, and said it would launch immediately under a Competitive Generic Therapy designation. Novo Nordisk's FREHEMGO (denecimig), a factor VIIIa-mimetic bispecific antibody for hemophilia A, received a positive CHMP opinion on Thursday, September 17, with once-monthly, every-two-week, and weekly dosing in a single-use pre-filled pen. The FDA approved Eli Lilly's Inluriyo (imlunestrant) with Verzenio (abemaciclib) for ESR1-mutated advanced breast cancer on Friday, September 18, based on a median progression-free survival of 11.1 months versus 5.5 months on imlunestrant alone in the EMBER-3 ESR1-mutated subgroup. Novartis received a positive CHMP opinion for Cosentyx (secukinumab) in polymyalgia rheumatica, which the company says would make it the first IL-17A inhibitor licensed in Europe for the disease.

Correction (September 23, 2026): This digest was revised to remove claims that could not be traced to a primary source and to replace general source links with specific ones. A Novo Nordisk Capital Markets Day preview item was removed: it described a Reuters interview with CEO Mike Doustdar as released on September 18, but that interview was published on August 13, 2026. The denecimig item previously listed only the FRONTIER-2 and FRONTIER-4 trials; Novo's announcement cites FRONTIER2, FRONTIER3, and FRONTIER4.

Regulatory

Amneal Wins FDA Approval and Launches Generic Lanreotide 120 mg Injection with Competitive Generic Therapy Designation; Reference Product Somatuline Depot Had $983M in U.S. Sales

Amneal Pharmaceuticals announced on Friday, September 18, 2026 that the FDA approved its lanreotide injection, 120 mg/0.5 mL, in a sterile single-dose prefilled syringe referencing Somatuline Depot, and that it would launch immediately. The product is indicated for acromegaly, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. The FDA gave it Competitive Generic Therapy designation. Somatuline Depot had U.S. sales of $983 million for the 12 months ended July 2026, according to IQVIA data cited by Amneal.

#amneal-pharmaceuticals #amrx #generic-lanreotide #lanreotide-injection #somatostatin-analog #somatuline-depot-reference #competitive-generic-therapy #acromegaly #gep-nets #carcinoid-syndrome #983-million-us-market #peptide-generic
Regulatory

Novo Nordisk FREHEMGO (Denecimig), a Factor VIIIa-Mimetic Bispecific Antibody, Receives Positive EU CHMP Opinion for Hemophilia A with Monthly, Every-Two-Week, or Weekly Dosing

Novo Nordisk announced on Thursday, September 17, 2026 that the EMA's CHMP recommended marketing authorization for FREHEMGO (denecimig) to treat hemophilia A, with or without inhibitors, in adults and children. Denecimig is a factor VIIIa-mimetic bispecific antibody that bridges factor IXa and factor X to mimic the cofactor function of activated factor VIII. Novo says it is the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks, and once-weekly prophylaxis in a single-use pre-filled pen. The application was based on the FRONTIER2, FRONTIER3, and FRONTIER4 trials, and FRONTIER5 showed no new safety signals in patients switching from emicizumab. Pending a European Commission decision, Novo expects launches in the first European countries in Q4 2026 and across the EU starting early 2027.

#novo-nordisk #novo #nvo #frehemgo #denecimig #factor-viiia-mimetic #bispecific-antibody #hemophilia-a #with-and-without-inhibitors #monthly-biweekly-weekly-dosing #prefilled-pen #chmp-positive-opinion #frontier-trials #q4-2026-eu-launch #non-peptide
Regulatory

FDA Approves Eli Lilly's Inluriyo (Imlunestrant) with Verzenio (Abemaciclib) for ESR1-Mutated Advanced Breast Cancer; Median PFS 11.1 vs 5.5 Months in EMBER-3 Subgroup

The FDA approved Eli Lilly's Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) on Friday, September 18, 2026 for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. The FDA also approved the Guardant360 CDx assay as the companion diagnostic for detecting ESR1 mutations. The approval rests on the EMBER-3 trial, which enrolled 874 adults; in the 159-patient ESR1-mutated subgroup, median progression-free survival was 11.1 months with the combination versus 5.5 months with imlunestrant alone (hazard ratio 0.53). Objective response rates were 35% and 15%, respectively.

#eli-lilly #lly #inluriyo #imlunestrant #verzenio #abemaciclib #cdk4-6-inhibitor #er-positive-her2-negative #esr1-mutated-breast-cancer #advanced-metastatic-breast-cancer #guardant360-cdx-companion-diagnostic #ember-3 #11-1-vs-5-5-month-mpfs #non-peptide
Regulatory

Novartis Cosentyx (Secukinumab) Receives Positive EU CHMP Opinion in Polymyalgia Rheumatica; Company Says It Would Be the First IL-17A Inhibitor Licensed in Europe for PMR

Novartis announced on Friday, September 18, 2026 that the CHMP adopted a positive opinion for Cosentyx (secukinumab) to treat polymyalgia rheumatica (PMR) in adults who have had an inadequate response to steroids or who relapse during steroid taper. Novartis says Cosentyx would be the first IL-17A inhibitor licensed in Europe for PMR. The opinion is based on the global Phase III REPLENISH trial, run in 27 countries, in which all primary and secondary endpoints were met across both the 300 mg and 150 mg arms; Cosentyx doubled sustained remission rates and delivered steroid-sparing effects versus placebo, with no new safety signals. The data were published in the New England Journal of Medicine, and the European Commission is expected to decide within about two months.

#novartis #nvs #novn #cosentyx #secukinumab #il-17a-inhibitor #monoclonal-antibody #polymyalgia-rheumatica #pmr #steroid-inadequate-response #chmp-positive-opinion #replenish-phase-3 #doubled-sustained-remission #steroid-sparing-effect #first-il-17-in-class-for-pmr #non-peptide

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