EMA Lands at Permanent Amsterdam Building as CHMP Recommends 5 New Medicines for Approval

Regulatory NewsRegulatory News | 15 November 2019 |  By 

As the European Medicines Agency (EMA) announced that it’s finally completing its move from London to Amsterdam, its Committee for Medicinal Products for Human Use (CHMP) on Friday recommended five new medicines for approval, revealed the outcomes of its safety reviews of Pfizer’s Xeljanz (tofacitinib) and Sanofi’s Lemtrada (alemtuzumab) and discussed the withdrawal of three applications.

Following the initial move to a temporary building in Amsterdam last March, EMA has been waiting on a new building with new technical equipment that was under construction. Staff will likely move into their new offices and workspaces in January 2020, the agency said. EMA previously said its total available workforce in Amsterdam is about 730, which is about 20% less than the 900 staffers EMA had in London.

“During the transitional period no face-to-face meetings will take place in the week 16-20 December 2019 except for EMA’s Management Board meeting on 18-19 December 2019 which will take place off-site,” EMA said. “During the week starting 6 January, no meetings will be held face-to-face and in the week starting 13 January the only meetings to be held face-to-face are those of EMA’s safety committee (PRAC) in the Spark building and of the herbal medicines committee (HMPC) and Scientific Advice Working Party (SAWP) in the new building.”

Approval Recommendations

CHMP gave a thumbs-up to Recordati’s orphan drug Isturisa (osilodrostat) for the treatment of Cushing’s syndrome, a rare disorder that occurs when the body produces too much corticosteroid hormone. The treatment has not been approved by the US Food and Drug Administration (FDA).

Novartis’ multiple sclerosis treatment Mayzent (siponimod) also received a positive opinion. FDA approved the drug in March.

Roche’s Polivy  (polatuzumab vedotin) received a recommendation for a conditional marketing authorization for the treatment of relapsed/refractory diffuse large B-cell lymphoma, a type of rare cancer of the white blood cells. Polivy received an accelerated approval in the US in June.

CHMP also adopted a positive opinion for Jazz Pharmaceutical’s Sunosi (solriamfetol), for the treatment of excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnea. The drug was approved by FDA in March.

And Rigel Pharmaceuticals’ Tavlesse (fostamatinib) received a positive opinion from CHMP for the treatment of primary immune thrombocytopenia. FDA approved Tavlesse in April 2018.

Earlier this week, the European Commission granted a conditional marketing authorization for Merck's Ebola vaccine. A decision from FDA on the vaccine is due 14 March 2020.

Safety Reviews

In addition to the approvals, CHMP recommended restricting the use of Sanofi’s multiple sclerosis medicine Lemtrada (alemtuzumab) following reports of rare but serious side effects, including deaths.

“Lemtrada should now only be used to treat relapsing-remitting multiple sclerosis if the disease is highly active despite treatment with at least one disease-modifying therapy or if the disease is worsening rapidly,” CHMP said. “Lemtrada must also no longer be used in patients with certain heart, circulation or bleeding disorders or in patients who have autoimmune disorders other than multiple sclerosis.”

And CHMP found that Pfizer’s Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk.

“As a result, the Committee recommended that Xeljanz should be used with caution in all patients at high risk of blood clots. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk of blood clots unless there is no suitable alternative treatment. 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,” CHMP said.

Applications Withdrawn

Meanwhile, Aradigm Pharmaceuticals late last month withdrew its application for a marketing authorisation of Linhaliq (ciprofloxacin) for treating and preventing flare-ups of bronchiectasis in patients with long-term lung infection caused by Pseudomonas aeruginosa bacteria. Aradigm received a complete response letter from FDA for the treatment in January 2018.

Kiadis Pharma Netherlands B.V. on 6 November also withdrew its application for Luxceptar (viable T-cells) for the treatment of patients with blood cancers who are receiving a type of blood stem cell transplant, CHMP said.

And Janssen-Cilag International withdrew its extension of indication application for the use of Opsumit (macitentan) to treat chronic thromboembolic pulmonary hypertension, a condition that causes high blood pressure in the lungs, according to CHMP. Opsumit was first approved in the US and EU in 2013 to treat pulmonary arterial hypertension.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019

Final Building in Amsterdam


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy