Shots:
- The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca.
- EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF); and Boey (trenibotulinumtoxinE) for the temporary improvement of moderate to severe glabellar lines in adults.
- Etcamah (camizestrant) was approved in combination with a CDK4/6 inhibitor for adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer with an ESR1 mutation and no disease progression following first-line endocrine therapy plus a CDK4/6 inhibitor, further expanding treatment options in oncology.
Company: Novartis
Product: Itvisma
Active Ingredient: Onasemnogene Abeparvovec
Disease: Spinal Muscular Atrophy
Date: Jul 16, 2026
Shots:
- The EC has approved Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene
- Approval was based on the P-III (STEER) trial & supportive P-IIIb (STRENGTH) & P-I/II (STRONG) studies, where STEER showed a 2.39-point improvement in the HFMSE with effects sustained over 52wks. vs 0.51 in Sham. Both STEER & STRENGTH demonstrated benefit in treatment-naïve as well as experience pts
- Itvisma is a gene replacement therapy that delivers a functional SMN1 gene via a single intrathecal dose, enabling sustained SMN protein expression to improve motor function in SMA pts
Company: Boehringer Ingelheim
Product: Jascayd
Active Ingredient: Onasemnogene Abeparvovec
Disease: Spinal Muscular Atrophy
Date: Jul 16, 2026
Shots:
- The EC has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) & adults with progressive pulmonary fibrosis (PPF)
- Approval was based on the P-III (FIBRONEER) program, comprising the FIBRONEER-IPF & FIBRONEER-ILD trials. Both met their 1EP, demonstrating that Jascayd slowed lung function decline, measured by the change in FVC from baseline to Wk. 52, compared with PBO
- Although the key 2EP was not met in either trial, Jascayd showed a numerical reduction in mortality across both studies, reaching nominal significance in FIBRONEER-ILD
Company: Allergan Aesthetics (AbbVie)
Product: Boey
Active Ingredient: TrenibotulinumtoxinE
Disease: Improve Glabellar Lines
Date: Jul 16, 2026
Shots:
- The EC has approved Boey (trenibotulinumtoxinE) to improve the appearance of mod. to sev. glabellar lines in adults temporarily across all 30 EEA countries
- Boey is Europe’s first and only rapid-onset, short-duration botulinum neurotoxin type E, with effects starting in as little as 8 hours and lasting 2–3 weeks.
- Boey also received Health Canada approval in June this year
Company: AstraZeneca
Product: Etcamah
Active Ingredient: Camizestrant
Disease: Advanced Breast Cancer
Date: Jul 22, 2026
Shots:
- The EC has approved Etcamah + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US
- Approval was based on the P-III (SERENA-6) trial assessing Etcamah + CDK4/6 inhibitor vs AI (anastrozole/letrozole) + CDK4/6 inhibitor in 315 pts with locally advanced or metastatic HR+/HER2- breast cancer harboring ESR1 mutation
- Trial showed a 56% reduction in the risk of disease progression or death (mPFS: 16 vs 9.2mos.), plus showed benefit in the time to second disease progression (25.7 vs 19.1mos.) & a favorable OS trend, which is under assessment. Data were published in The NEJM
