The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has rejected the marketing application for abaloparatide (Radius Health) subcutaneous injection for postmenopausal women with osteoporosis at increased risk for fracture, the company has announced.
The CHMP issued its negative opinion on abaloparatide today.
Radius said it intends to appeal and immediately seek a re-examination of the CHMP opinion.
The US Food and Drug Administration (FDA) approved abaloparatide, as Tymlos, in April 2017 for use in postmenopausal women with osteoporosis at high risk for fracture due to a history of osteoporotic fracture, those with multiple risk factors for fracture, or patients who have not responded to or are intolerant of other available osteoporosis therapy.
Abaloparatide was the first new anabolic treatment approved for postmenopausal women with osteoporosis in the United States in nearly 15 years, and since its approval, over 5000 patients have been treated with Tymlos in the United States, says the company.
The US approval of abaloparatide was based on 18-month results from the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial and results from the first 6 months of the ACTIVExtend trial.
Radius has just reported more data from this trial, at the recent ENDO 2018 meeting. In follow-up of ACTIVExtend, sequential treatment with abaloparatide followed by alendronate led to greater increases in bone mineral density (BMD) in women with osteoporosis compared with those treated with placebo followed by alendronate.
At the 43-month timepoint, 60.7% (n = 307/506) of patients receiving abaloparatide followed by alendronate experienced BMD increases of more than 3% at all the lumbar spine, total hip, and femoral neck (P < .0001) compared with 24% (n = 121/505) of patients who received placebo followed by alendronate. Increases of more than 6% at all three sites were experienced by 33.2% (n = 168/506) of patients receiving abaloparatide followed by alendronate compared with 4% (n = 20/505) of patients who received placebo followed by alendronate (P < .0001).
“While we are disappointed with the CHMP’s assessment, we are confident in abaloparatide-SC and our clinical trial data supporting the marketing authorization approval, which was also the basis for FDA approval of the product in the U.S.,” said Jesper Høiland, president and chief executive officer of Radius Health, in a statement.
“We remain focused on the commercialization of Tymlos in the U.S., the largest market in revenues for anabolics globally, and continue our efforts to make abaloparatide-SC available in Japan through our collaboration with Teijin, as well as in other markets through partnership agreements.”
If eventually approved in the EU, abaloparatide will be known there as Eladynos.
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