Sobi announced positive results from the AVA-PED-301 study (NCT04516967), evaluating the efficacy and safety of avatrombopag (Doptelet) for the treatment of paediatric patients with immune thrombocytopenia (ITP) of at least 6 months’ duration.
The Lancet has published clinical trial data for aflibercept 8 mg (Eylea 8 mg) from the pivotal phase III PULSAR study in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON study in diabetic macular edema (DME) in the first year of treatment (at week 48).
Astellas Pharma Europe Ltd. has announced the publication in the European Journal of Pain of a head to head, non-inferiority...
Regeneron Pharmaceuticals, Inc. announced that the primary endpoints were met in two pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD)
Bayer announced two-year (96 weeks) topline results of the pivotal clinical trial PULSAR in patients with neovascular (wet) age-related macular degeneration (nAMD). The data reinforce sustained vision gains with unprecedented extended treatment intervals of aflibercept 8 mg reaching up to 24 weeks with efficacy and safety comparable to the current standard of care Eylea (aflibercept 2 mg) with fixed intervals of 8 weeks.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending aflibercept 8 mg with extended treatment intervals in two major retinal eye diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) for approval
Regeneron Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), solely due to an ongoing review of inspection findings at a third-party filler
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted market authorization for Eylea 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME)
Regeneron Pharmaceuticals announced results from its Phase II proof-of-concept trial evaluating an investigational 8 mg high dose of aflibercept compared to the currently-approved 2 mg dose of Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).