Recommendations for Mayzent, Polivy lead decisions from CHMP's November meeting

At its November meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended seven drugs for approval, as well as two line extensions. The committee also started the re-examination of a previous negative opinion on one medicine, while three companies withdrew marketing applications. All of the decisions can be found detailed below.

Positive recommendations on new medicines:

  • Isturisa (osilodrostat) for the treatment of endogenous Cushing's syndrome in adults. Recordati recently acquired rights to the cortisol synthesis inhibitor from Novartis.
  • Mayzent (siponimod) for the treatment of adults with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity. Novartis' selective sphingosine 1-phosphate receptor modulator gained FDA approval earlier this year.
  • Polivy (polatuzumab vedotin) in combination with bendamustine plus MabThera (rituximab) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, who are not candidates for a haematopoietic stem cell transplant. Roche's antibody-drug conjugate, which targets CD79b, was granted accelerated approval in the US in June.
  • Sunosi (solriamfetol) for the treatment of excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnoea. Jazz Pharmaceuticals' dual-acting dopamine and norepinephrine reuptake inhibitor garnered FDA clearance in March.
  • Tavlesse (fostamatinib) for the treatment of chronic immune thrombocytopenia in adults who are refractory to other treatments. Rigel Pharmaceuticals' SYK inhibitor gained authorisation in the US last year where it is sold as Tavalisse, while Grifols will commercialise the drug in Europe.
  • Mylan's generic version of Sanofi and Bristol-Myers Squibb's DuoPLavin (clopidogrel/acetylsalicylic) for the secondary prevention of atherothrombotic events.
  • Accord Healthcare's generic version of Novartis' Exjade (deferasirox) for the treatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia and other anaemias.

Positive recommendations on extensions of therapeutic indications:

  • Roche's antibody-drug conjugate Kadcyla (trastuzumab emtansine) for the adjuvant treatment of adults with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
  • Celgene's Revlimid (lenalidomide) in combination with MabThera (rituximab) for the treatment of adults with previously treated follicular lymphoma.

Start of re-examination of recommendation for new medicine:

  • D&A Pharma requested a re-examination of a negative opinion issued last month on Hopveus (sodium oxybate) to treat alcohol dependence in patients in whom other treatments are not effective or cannot be used. The CHMP previously concluded that although some studies suggested the medicine could be effective, this was not conclusively demonstrated, while there were also concerns regarding its misuse and abuse potential.

Withdrawal of marketing authorisation applications:

  • Aradigm withdrew its application on October 29 seeking approval of Linhaliq (ciprofloxacin) for the treatment and prevention of flare-ups of non-cystic fibrosis bronchiectasis in patients with long-term lung infection caused by Pseudomonas aeruginosa bacteria. The company pulled the filing after the CHMP raised concerns that studies did not show convincingly that the medicine was effective.
  • Kiadis Pharma withdrew is submission for Luxceptar for the treatment of patients with blood cancers receiving T-cell depleted blood stem cell transplants. The company announced last month that it expected to receive a negative opinion from the CHMP on the filing, while last week it said it would end development of the T-cell based therapy, also known as ATIR101, as a Phase III study was unlikely to deliver positive results.
  • Johnson & Johnson's Actelion division withdrew an application on November 8 to extend the use of Opsumit (macitentan) to include the treatment of adults with inoperable chronic thromboembolic pulmonary hypertension. The company pulled the filing, as well as other submissions, including in the US, after regulators indicated that additional clinical data would be required for approval. The EMA noted that results of the main trial supporting the application were "difficult to interpret, and there were several deviations from the study protocol which may have made the results less reliable."

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