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Five drugs, including two Novartis therapies, win EMA endorsement

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

The company has also secured a positive EMA recommendation for Isturisa — known chemically as osilodrostat — for use in Cushing’s syndrome, a disease characterized by the exaggerated production of the hormone cortisol. Earlier this year, Novartis palmed off three endocrine drugs, including osilodrostat, to Italy’s Recordati for $390 million upfront. It also stands to make more in milestone payments tied to osilodrostat.

Fellow Swiss drug giant Roche also scored the EMA endorsement for its latest antibody-drug conjugate (ADC), Polivy. The drug, known chemically as polatuzumab vedotin, has already won US approval in patients with diffuse large B-cell lymphoma as part of a regimen that includes the chemotherapy bendamustine and a version of its aging blockbuster cancer drug, Rituxan. The combination is reminiscent of Roche’s first cleared ADC regimen, Kadcyla, which includes its bestselling cancer drug Herceptin and a chemotherapy agent.

Jazz Pharmaceuticals, which scored US approval for its wake-promoting drug solriamfetol, christened Sunosi, in March — now has the EMA’s blessing. Like Xyrem — the blockbuster narcolepsy drug that accounts for the bulk of Jazz’s sales — the dual-acting dopamine and norepinephrine reuptake inhibitor is designed to treat excessive daytime sleepiness for patients with obstructive sleep apnea (OSA) as well as narcolepsy.

Rigel’s Tavlesse, known chemically as fostamatinib, was approved last year by the FDA as a second-line therapy for thrombocytopenia in adult patients with chronic immune thrombocytopenia. The drug, which is designed to block spleen tyrosine kinase (SYK), and reduces antibody-mediated destruction of platelets, now has the EMA’s backing.

The EMA also backed the approval of two generic medicines and recommended expanding the labels of Roche’s Kadcyla and Celgene’s Revlimid. The European Commission typically issues its decisions about two months following its committee’s recommendations.

The use of two approved drugs was also restricted by the agency’s human medicines committee (CHMP).

The committee endorsed the decision of the EMA’s safety panel, concluding that the use of Pfizer’s blockbuster JAK inhibitor Xeljanz could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk. After reviewing all the data, including the ongoing study A3921133 in patients with rheumatoid arthritis, the agency said it was cautioning the use of the drug in all patients at high risk of blood clots.

In February, Pfizer ousted the 10 mg dose from the A3921133 study, switching patients to the smaller 5 mg dose after documenting “a statistically and clinically important difference in the occurrence of pulmonary embolism” as well as an imbalance in mortality rate.

The EMA panel also banned the use of the 10 mg twice daily in patients with ulcerative colitis who are at high risk of blood clots, unless there is no suitable alternative treatment. Further, the EMA is recommending that, due to an increased risk of infections, patients older than 65 years of age should be treated with Xeljanz only when there is no alternative treatment, it said. These recommendations follow a limit imposed by the EMA safety committee in May.

Meanwhile, Sanofi’s relapsing-remitting multiple sclerosis drug Lemtrada was also restricted in a recommendation by the CHMP. Reports of immune-mediated conditions and problems with the heart and blood vessels with the medicine, including fatal cases, triggered a review in April by the agency’s safety panel and a recommendation for limited use.

Written by: Natalie Grover


Published in: November 15, 2019 10:21 AM EST

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