1. RINVOQ® showed higher hair regrowth rates in severe alopecia areata
On Aug 21, 2025, Abbvie announced that positive results from study 1 of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of RINVOQ® (Upadacitinib) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 84.0 (approximately 16% scalp hair coverage). Upadacitinib is a JAK inhibitor blocking JAK1 signalling and regulating cytokine-mediated inflammation and immune responses in autoimmune diseases. AT week 24, both 15 mg and 30 mg dose groups achieved the primary endpoint, with 45.2% and 55.0% of patients reaching 80% or more scalp hair coverage (SALT score ≤ 20), compared to 1.5% of patients under placebo. Secondary endpoints of improvements in eyebrows and eyelashes were also increased in the treatment group with both dosages.
2. FDA grants Breakthrough Therapy Designation to izalontamab brengitecan for previously treated EGFR-mutated NSCLC
On Aug 18, 2025, SystImmune and BMS announced that izalontamab brengitecan (iza-bren) has been granted Breakthrough Therapy Designation (BTD) from the U.S. FDA to treat patients with previously treated EGFR-mutated non-small cell lung cancer (NSCLC). Iza-bren is a bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3 with a topoisomerase 1 inhibitor payload. The FDA’s decision was based on the efficacy and safety data from three ongoing clinical trials: BL-B01D1-101 and BL-B01D1-203. Across these trials, iza-bren showed improved efficacy with a manageable safety profile in patients with EGFR-mutant NSCLC who had progressed after third-generation EGFR TKIs and platinum-based chemotherapy.
3. European Commission approves new film-coated tablet formulation of BRUKINSA®
On Aug 21, 2025, BeOne Medicines announced that the European Commission has approved a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) for all approved indications. Zanubrutinib is an anticancer medication that inhibits BTK, which is used for the treatment of different types of lymphomas. The new formulation will reduce pill burden and enhance administration convenience.
4. FDA grants Breakthrough Therapy Designation to Ifinatamab deruxtecan for small cell lung cancer
On Aug 18, 2025, Daiichi-Sankyo and Merck announced that Ifinatamab deruxtecan (I-DXd, a B7-H3 directed ADC) has been granted Breakthrough Therapy Designation (BTD) by the U.S. FDA to treat adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. B7-H3, also known as CD267, is a protein that plays a significant role in promoting tumor growth and immune evasion. The Breakthrough Therapy Designation is based on the data from the IDeate-Lung01 phase 2 trial.
Link: https://www.daiichisankyo.com/files/news/pressrelease/pdf/202508/20250818_E.pdf
5. FDA approves DAWNZERA™ (donidalorsen) for prophylaxis of hereditary angioedema in patients 12 years and older
On Aug 21, 2025, Ionis Pharmaceuticals announced that the U.S. FDA had approved DAWNZERA™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. Hereditary Angioedema (HAE) is a rare, genetic disorder causing recurrent, severe swelling in various body parts, including the face, limbs, intestines, and airway. DAWNZERA is an RNA-targeted medicine which is designed to target plasma prekallikrein (PKK). The approval of DAWNZERA was based on positive results from the Phase 3 OASIS-HAE study. The primary endpoint has been achieved with a significant reduction of the monthly HAE attack rate by 81% compared to placebo over 24 weeks. The switch cohort also shows that switching to DAWNZERA reduced the mean HAE attack rate by 62% from prior prophylactic treatment over 16 weeks.
6. FDA approves Tonmya™ (cyclobenzaprine HCl sublingual tablets) for treatment of fibromyalgia in adults
On Aug 15, 2025, Tonix Pharmaceuticals announced that the U.S. FDA had approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Fibromyalgia is a long-term condition that involves widespread body pain. Tonmya is a bedtime analgesic administered under the tongue. The approval was based on two Phase 3 clinical studies, where Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks (1.8 points vs. 1.2 points). Additionally, many study participants taking Tonmya experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to the placebo arm.
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