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Regulatory Focus™ > News Articles > 3 > EMA’s CHMP Rejects Two Drugs Approved by US FDA in 2017

EMA’s CHMP Rejects Two Drugs Approved by US FDA in 2017

Posted 23 March 2018 | By Zachary Brennan 

EMA’s CHMP Rejects Two Drugs Approved by US FDA in 2017

The European Medicines Agency (EMA) on Friday raised questions about two treatments approved by the US Food and Drug Administration (FDA) in 2017.

EMA’s Committee for Medicinal Products for Human Use (CHMP) on Friday adopted negative opinions for two medicines - Dexxience (betrixaban), approved by the US Food and Drug Administration (FDA) in June 2017 as Bevyxxa (betrixaban) to prevent venous thromboembolism, and Eladynos (abaloparatide), approved by the US Food and Drug Administration (FDA) in May 2017 as Tymlos (abaloparatide) for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

In the case of 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. Moreover, the results of the study were not considered reliable because some results of tests for blood clots were not available. Patients treated with Dexxience had more episodes of bleeding than those treated with the comparator medicine. This was considered an important concern given that the medicine was expected to be used in patients with serious underlying conditions. Therefore, the CHMP concluded that the benefits of Dexxience did not outweigh its risks and recommended that it be refused marketing authorisation.”

And 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.”

“From a safety point of view, the CHMP was concerned about the medicine’s effects on the heart, such as increases in heart rate and palpitations. Because most post-menopausal women are at an increased risk of heart problems, the CHMP could not identify a group of patients in whom the benefits would outweigh the risks. Therefore, the committee recommended that the medicine be refused marketing authorization,” CHMP said.

These two are also not the only times in recent months when EMA has taken a different view than FDA.

On 22 February, CHMP adopted a negative opinion for Puma Biotechnology’s Nerlynx (neratinib), intended for the treatment of breast cancer, approved under the same name by FDA in July 2017.

CHMP Recommendations

CHMP also announced Friday that it recommended six medicines for approval, including two generic drugs.
Among those were a conditional marketing authorization for Clovis Oncology’s orphan medicine Rubraca (rucaparib), for the treatment of relapsed or progressive ovarian cancer. Rubraca was designated as an orphan medicine during its development, approved by FDA in December 2016.

And Janssen and ViiV Healthcare’s Juluca (dolutegravir/rilpivirine) received a positive opinion for the treatment of human immunodeficiency virus (HIV) infection, which was approved by FDA in November.
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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