CHMP Recommends Expanded EU Indication for Amgen’s Repatha to Reduce First Heart Attack and Stroke Risk In Adults

Shots:Amgen announced that the CHMP issued a positive opinion recommending an expanded indication for Repatha (evolocumab) to reduce cardiovascular risk in adults with established or high risk for atherosclerotic cardiovascular disease by lowering LDL-C levels, alongside correction of other risk factorsThe recommendation is supported by the P-III (VESALIUS-CV) study involving ≥12,000 pts., Repatha…

ByPrince Giri12 hours ago

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CHMP Recommends Expanded EU Indication for Amgen’s Repatha to Reduce First Heart Attack and Stroke Risk In Adults

Shots:Amgen announced that the CHMP issued a positive opinion recommending an expanded indication for Repatha (evolocumab) to reduce cardiovascular risk in adults with established or high risk for atherosclerotic cardiovascular disease by lowering LDL-C levels, alongside correction of other risk factorsThe recommendation is supported by the P-III (VESALIUS-CV) study involving ≥12,000 pts., Repatha…

ByPrince Giri12 hours ago

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Cytokinetics Reports MHRA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots:The MHRA has approved Cytokinetics’ Myqorzo (aficamten) for the treatment of adults with symptomatic (NYHA, class II-III) oHCMMHRA assessment was based on P-III (SEQUOIA-HCM) trial of Myqorzo (n=282), showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/minAdditionally, NICE has recommended aficamten for eligible…

ByRidhi Rastogi1 day ago

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Nippon Shinyaku Exercises US Option for AB2 Bio’s Tadekinig Alfa

Shots:Nippon has exercised its exclusive US commercialization option for tadekinig alfa in Primary Monogenic IL-18-Driven Hyperinflammatory Syndrome with NLRC4 & XIAP mutations, with AB2 Bio retaining US rights to all other indications & all rights outside the USAB2 Bio received a $6M option fee in 2025 & will now receive a $30M option…

ByRidhi Rastogi2 days ago

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Incyte Reports EC Approval of Opzelura (Ruxolitinib) Cream for Moderate Atopic Dermatitis

Shots:The EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adults for whom topical corticosteroids (TCSs) & topical calcineurin inhibitors (TCIs) are inadequate or inappropriateApproval was based on the P-IIIb (TRuE-AD4) study assessing Opzelura vs vehicle in 241 adults with moderate AD, which met its co-1EPs of EASI75…

ByRidhi Rastogi2 days ago

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Dyne Therapeutics Reports IND Clearance to Initiate P-I Trial of DYNE-302 for FSHD

Shots:The US FDA has granted IND clearance to initiate a P-I multiple ascending dose trial assessing DYNE-302 against PBO in ambulatory adults with facioscapulohumeral muscular dystrophy (FSHD)In the first cohort, 9 pts will receive DYNE-302 (1.5 mg/kg, Q4W) or PBO, with higher doses & less frequent dosing planned. Pts completing the PBO-controlled phase…

ByRidhi Rastogi3 days ago

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Daiichi Sankyo and AstraZeneca Report CHMP Positive Opinion for Enhertu + Perjeta to Treat HER2-Positive Metastatic Breast Cancer

Shots:The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157)Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy,…

ByRidhi Rastogi4 days ago

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Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

Shots:The CHMP has recommended Susvimo (100mg/mL) for the treatment of neovascular age-related macular degeneration (nAMD)The opinion was based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal), where Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to Lucentis (QM, IVT), with Portal showing maintenance of vision up…

ByRidhi Rastogi4 days ago

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Otsuka Reports the US FDA Approval for Simtriyo to Treat ADHD

Shots:The US FDA has approved Simtriyo (centanafadine) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pts (≥6yrs.; ≥20kg), with availability expected later this year following scheduling by the US DEAApproval was supported by 4 P-III trials assessing Simtriyo vs PBO in children, adolescents, & adults with ADHDIn two adult studies, both Simtriyo dose groups…

ByRidhi Rastogi5 days ago

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Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Shots:The US FDA has granted Fast Track designation to Lu AH69593 for the treatment of patients with narcolepsyLu AH69593 is a small-molecule orexin 2 receptor agonist being developed by Lundbeck for narcolepsy to regulate arousal, wakefulness, & sleep-wake stabilityLu AH69593 is being evaluated in a P-Ib clinical program, with Lundbeck continuing to…

ByRidhi RastogiJuly 24, 2026

CHMP Recommends Expanded EU Indication for Amgen’s Repatha to Reduce First Heart Attack and Stroke Risk In Adults

CHMP Recommends Expanded EU Indication for Amgen’s Repatha to Reduce First Heart Attack and Stroke Risk In Adults

Cytokinetics Reports MHRA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Nippon Shinyaku Exercises US Option for AB2 Bio’s Tadekinig Alfa

Incyte Reports EC Approval of Opzelura (Ruxolitinib) Cream for Moderate Atopic Dermatitis

Dyne Therapeutics Reports IND Clearance to Initiate P-I Trial of DYNE-302 for FSHD

Daiichi Sankyo and AstraZeneca Report CHMP Positive Opinion for Enhertu + Perjeta to Treat HER2-Positive Metastatic Breast Cancer

Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD

Otsuka Reports the US FDA Approval for Simtriyo to Treat ADHD

Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

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