EU rejects two drugs approved by the USFDA

Last week, the European Medicines Agency (EMA) raised questions about two treatments approved by the USFDA in 2017. EMA’s Committee for Medicinal Products for Human Use (CHMP) then rejected two medicines, Dexxience (betrixaban), approved by the USFDA in June 2017 as Bevyxxa (betrixaban) to prevent venous thromboembolism, and Eladynos (abaloparatide), approved by the USFDA in May 2017 as Tymlos (abaloparatide) for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
There have been similar instances of EMA rejecting drugs approved by the USFDA in the recent past. In February this year, the CHMP had adopted a negative opinion for Puma Biotechnology’s Nerlynx (neratinib), intended for treatment of breast cancer, approved under the same name by the USFDA in July 2017.
For betrixaban, CHMP said: “The main study did not satisfactorily show that Dexxience’s benefits outweighed its risk when used for preventing blood clots in patients admitted to hospital for recent medical illness.”
For abaloparatide, CHMP said: “The main study did not satisfactorily show that Eladynos is effective at preventing non-vertebral fractures in women who have been through the menopause. The data from two of the study sites were not reliable and had to be excluded as the study had not been conducted in compliance with ‘good clinical practice’ (GCP) at those sites.”
Meanwhile, the CHMP has recommended six medicines for approval, including two generic drugs. These include Clovis Oncology’s Rubraca (rucaparib) for treatment of relapsed or progressive ovarian cancer; and ViiV Healthcare’s Juluca (dolutegravir/rilpivirine) for the treatment of human immunodeficiency virus (HIV) infection, which was approved by the USFDA in November 2017.
Two biosimilars were also recommended by CHMP: Amgen and Allergan’s Kanjinti (trastuzumab) for the treatment of breast and gastric cancer; and Sandoz’s Zessly (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
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