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Novartis’ Mayzent and Roche’s Polivy lead CHMP recommendations

Sanofi Genzyme’s Lemtrada and Pfizer's Xeljanz receive label restrictions

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The first drug to treat disease progression in patients with an advanced form of multiple sclerosis was among five new medicines recommended for use in Europe on Friday. 

Mayzent (siponimoid), developed by Swiss pharma Novartis, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS).

SPMS is typically characterised by an irreversible decline of neurological functions – if Mayzent receives approval from the EMA, which is likely following the CHMP recommendation, it will become the first oral treatment for this type of MS in Europe.

“Today’s CHMP opinion marks a milestone in supporting people in Europe who are living with active SPMS,” said Christoph Thalheim, director of external affairs, European Multiple Sclerosis Platform.

“Today’s CHMP opinion marks a milestone in supporting people in Europe who are living with active SPMS,” he added.

Roche’s Polivy (polatuzumab vedotin) has also been granted a conditional marketing authorisation for the treatment of relapsed/refractory diffuse large B-cell lymphoma – a rare type of cancer that affects white blood cells.

Following this conditional approval, a final decision regarding Polivy is expected from the European Commission in the near future.

Polivy's recommendation is based on the results from Roche’s phase 1b/2 GO29365 study, which showed that 40% of people treated with the drug, plus bendamustine and rituximab (BR), achieved a complete response, compared to 17.5% of those treated only with BR.

This means that no cancer could be detected at the time of assessment – a significant benefit for patients with otherwise limited treatment options.

Novartis Europharm also gained a marketing authorisation for Isturisa (osilodrostat) for the treatment of Cushing’s syndrome – a rare disorder that occurs when the body produces too much corticosteroid hormones. This in turn leads to weight gain, fat build-up on the face and bruising.

Rounding out the new medicines approval was Jazz Pharmaceutical’s Sunosi (solriamfetol), which gained a positive opinion for the treatment of excessive daytime sleepiness in patients with narcolepsy, a sleep disorder that causes individuals to fall asleep suddenly, and obstructive sleep apnoea.

The CHMP also recommended marketing authorisations for two generic medicines – Mylan’s Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel/acetylsalicylic acid) for the secondary prevention of atherothrombotic events and Accord’s Healthcare’s Deferasirox Accord (deferasirox) for the treatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia and other anaemia types.

Safety reviews of Lemtrada and Xeljanz

In addition to approving a number of new drugs, the CHMP also restricted the use of two medicines.

This includes Sanofi Genzyme’s multiple sclerosis medicine Lemtrada (alemtuzumab), which now has restricted use due to reports of rare but serious side effects, including death. The side effects include cardiovascular disorders and immune-related disorders.

Lemtrada is now restricted for use only in the treatment of relapsing-remitting MS if the disease is highly active, despite treatment with at least one disease-modifying therapy, or if the disease is worsening rapidly.

It is also restricted for use by patients with certain heart, circulation or bleeding disorders, or in patients who have autoimmune disorders other than MS.

Also receiving a recommendation for restriction is Pfizer’s rheumatoid arthritis medication Xeljanz (tofacitinib), after the EMA concluded that it could increase the risk of blood clots in the lungs and deep veins in high-risk patients.

This follows the FDA in the US issuing a formal warning about the risks of the JAK inhibitor earlier this year, after a post-marketing study if the drug showed a 10mg dose could increase the risk of life-threatening blood clots.

The agency is recommending that Xeljanz should now be used with caution in all high-risk patients, and that the maintenance doses of 10mg twice daily should not be used in patients with ulcerative colitis – unless there is no alternative treatment.

Article by
Lucy Parsons

18th November 2019

From: Regulatory



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