CHMP Recommends Withdrawal of Novartis' Sickle Cell Drug Adakveo Marketing Authorization in EU

May 29, 2023 18:10 CST Updated 18:10

Novartis

Drug Development and Manufacturing

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

On May 26, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the revocation of Novartis' conditional marketing authorization for Adakveo (crizanlizumab), a drug used to treat Sickle Cell Disease (SCD). The CHMP recommendation has been submitted to the European Commission (EC), which is expected to make a final decision within two months.

This recommendation is primarily based on the results of the Phase III STAND (NCT03814746) study of Adakveo in preventing vaso-occlusive crises (VOC) in patients with sickle cell disease (SCD). Compared with placebo, Adakveo failed to reduce the incidence of VOC at two different dose levels (5.0mg/kg, 7.5mg/kg).

Novartis stated that no new patients in the EU will receive crizanlizumab treatment. For patients currently using crizanlizumab, healthcare professionals should discuss alternative treatment options with them.

Crizanlizumab is a humanized monoclonal antibody that exerts its therapeutic effect by binding to P-selectin. P-selectin is a protein found on the surface of vascular endothelial cells and platelets, primarily responsible for intercellular interactions and involved in thrombosis or pain crises associated with sickle cell disease.

In November 2016, Novartis acquired Selexys Pharmaceuticals for $665 million, obtaining the ownership of crizanlizumab. In November 2019, crizanlizumab was approved by the FDA for marketing to reduce the frequency of VOC in SCD patients over 16 years old, with the trade name Adakveo. In October 2020, the product entered the EU market. In terms of market performance, the product's sales in 2022 were $194 million.

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