Novartis sickle cell drugs approval formally revoked by EU regulators
The decision followed a May recommendation by the European Medicines Agency to withdraw marketing authorization of the drug, called Adakveo.
Novartis will withdraw its sickle cell disease drug Adakveo from the European market after authorities there formally revoked the treatment’s authorization.
In an emailed statement, Novartis said that patients currently on Adakveo should discuss alternative treatment options with their physician. The company did not answer a question from BioPharma Dive on how long the withdrawal process will take.
No new safety concerns were identified with the medicine, Novartis noted.
The European Commission’s decision is legally binding and covers all 27 EU countries, along with Iceland, Norway, Liechtenstein and Northern Ireland. (Northern Ireland is following EU centralized procedures until January 2025.)
An antibody drug, Adakveo was approved in Europe in late 2020 to prevent vaso-occlusive crises, which are a typical symptom of severe sickle cell. The drug binds to a substance called P-selectin that’s found on the surface of blood vessel cells. Blocking P-selectin is thought to prevent the clogging up of blood vessels during pain crises.
The drug is also approved in the U.S., and Novartis said it is discussing the recent negative study findings with the Food and Drug Administration.
Globally, some 11,800 people with sickle cell have received Adakveo, according to the company. Over the first six months of the year, Novartis reported just over $100 million in sales.
In the U.S., it arrived on market alongside a drug from Global Blood Therapeutics that’s now owned by Pfizer. While the treatments were welcomed as important new options, they’ve gone relatively little used, according to reporting by Stat. Both are expensive, and neither are considered cures for sickle cell, which is caused by red blood cells deforming into crescents that stick and snag in blood vessels.
They’ve also arrived as potent genetic medicines for the disease near market. Later this year, two gene-correctivetreatments that are seen as potentially curative could win FDA approval.
Let’s apply Data-Driven Pricing to Your APIs
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions!
Learn More!