PharmaMar’s MM drug gets another chance to win approval in Europe

2024-07-09

Nearly eight years after PharmaMar first sought EU approval of its multiple myeloma (MM) drug Aplidin (plitidepsin) — and following back-to-back rejections by a drug advisory body for the European Medicines Agency (EMA) — the Spanish drugmaker has got a second wind.

The European Commission (EC) ruled that during Aplidin’s initial review by the EMA’s Committee for Medicinal Products for Human Use (CHMP), one of the participants was involved in the development of a rival product.

“Consequently, in order to avoid any doubt as to the objective impartiality of the assessment of the application, the Commission has decided it is appropriate to revoke the decision to refuse marketing authorisation for Aplidin,” PharmaMar said in a statement.

The EMA will now review CHMP’s earlier regulatory opinions on Aplidin and reevaluate the candidate’s application “from the time of the onset of the detected procedural irregularity.”

Legal saga

The committee had first rejected PharmaMar’s application for Aplidin in late 2017 and again in early 2018, after which the company filed a lawsuit against the EC seeking the annulment of the regulator’s decision.

PharmaMar was successful in its suit in October 2020, with the General Court of the EU ruling in favour of an annulment due to conflict of interest.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构