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Zepbound Demonstrates Superior Weight Loss Over Wegovy; FDA Actions Advance Lung Cancer and Psoriatic Arthritis Therapies

• Eli Lilly's Zepbound showed a 47% greater relative weight loss compared to Novo Nordisk’s Wegovy in a head-to-head obesity study. • Merck's sacituzumab tirumotecan (Sac-TMT) received FDA Breakthrough Therapy designation for advanced NSCLC with EGFR mutations. • AstraZeneca's Imfinzi gained FDA approval for limited-stage small cell lung cancer (LS-SCLC) based on positive Phase III ADRIATIC trial data. • J&J submitted applications to the FDA for Tremfya's use in pediatric patients with plaque psoriasis and juvenile psoriatic arthritis.

Eli Lilly's Zepbound (tirzepatide) has demonstrated superior weight loss compared to Novo Nordisk's Wegovy (semaglutide) in the SURMOUNT-5 study, marking a significant advancement in obesity treatment. The FDA also granted Breakthrough Therapy designation to Merck's sacituzumab tirumotecan for certain non-small cell lung cancer (NSCLC) patients and approved AstraZeneca's Imfinzi for limited-stage small cell lung cancer (LS-SCLC).

Zepbound Outperforms Wegovy in Head-to-Head Trial

The SURMOUNT-5 trial revealed that Zepbound achieved an average weight loss of 20.2%, significantly higher than the 13.7% observed with Wegovy. This translates to a 47% greater relative weight loss for individuals using Zepbound. Participants on Zepbound experienced an average weight loss of 50.3 lbs (22.8 kg), compared to 33.1 lbs (15.0 kg) for those on Wegovy. Notably, 31.6% of Zepbound users achieved a weight loss of at least 25% of their body weight, versus 16.1% for Wegovy users. The safety profile of Zepbound was consistent with previous studies.

Merck's Sacituzumab Tirumotecan Gains Breakthrough Therapy Designation

Merck's sacituzumab tirumotecan (Sac-TMT), a TROP2-directed antibody-drug conjugate (ADC), has received FDA Breakthrough Therapy designation for treating advanced or metastatic nonsquamous NSCLC with EGFR mutations after prior treatment. This designation aims to expedite the development and review of drugs for serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies. Sac-TMT is being developed in partnership with Kelun-Biotech and is currently being evaluated in multiple Phase III trials across various solid tumors, both as a monotherapy and in combination with Keytruda.

Imfinzi Approved for Limited-Stage Small Cell Lung Cancer

AstraZeneca's Imfinzi (durvalumab) has secured FDA approval for the treatment of limited-stage small cell lung cancer (LS-SCLC) in patients who have not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was based on data from the Phase III ADRIATIC study, which demonstrated a statistically significant improvement in overall survival. Imfinzi, a PD-L1 inhibitor, is already approved for various other cancer indications, including stage III non-small cell lung cancer and extensive-stage SCLC.

J&J Seeks Approval for Tremfya in Pediatric Psoriatic Conditions

Johnson & Johnson (J&J) has submitted supplemental Biologics License Applications (sBLAs) to the FDA seeking approval for Tremfya (guselkumab) in pediatric patients. The applications cover the treatment of moderate-to-severe plaque psoriasis in children aged 6 years and older, and active juvenile psoriatic arthritis in children aged 5 years and older. Tremfya, an IL-23 inhibitor, is currently approved for treating certain adult patients with plaque psoriasis and active psoriatic arthritis. It is also under review for ulcerative colitis and Crohn’s disease.
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Reference News

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Novartis ramps up in radiopharma, and Eli Lilly adds Zepbound details - STAT News
statnews.com · Nov 18, 2024

Syndax Pharmaceuticals wins FDA approval for Revuforj, a leukemia treatment; Cybin's psilocin-based drug shows efficacy ...

[2]
Pharma Stock Roundup: LLY's Zepbound Success, FDA Updates for MRK, JNJ
finance.yahoo.com · Dec 6, 2024

Eli Lilly's Zepbound showed 47% greater weight loss than Novo Nordisk's Wegovy in SURMOUNT-5 study. FDA granted Breakthr...

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