MHRA revokes Novartis’ Adakveo authorisation for sickle cell disease

22 Feb 2024
www.pharmaceutical-technology.com
Phase 3Accelerated ApprovalDrug Approval
MHRA revokes Novartis’ Adakveo authorisation for sickle cell disease
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Source: Pharmaceutical Technology
The decision was made after the Phase III STAND study failed to validate the clinical benefit of Adakveo in treating sickle cell disease patients. Credit: Victor Josan / Shutterstock.com.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has revoked a conditional marketing authorisation for Novartis Pharmaceuticals’ Adakveo 10mg/ml concentrate for solution for infusion to treat sickle cell disease.
The decision was made after the Phase III STAND study failed to validate the clinical benefit of Adakveo in treating patients who have vaso-occlusive crises.
Novartis is recalling the product as the MHRA no longer deems its benefit-risk balance favourable.
Healthcare professionals were instructed by the regulator to immediately stop the supply of the affected batch and quarantine remaining stock.
Novartis, which has a direct-to-pharmacy supply chain agreement, is aware of the hospitals that received the impacted batch.
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MHRA revokes Novartis’ Adakveo authorisation for sickle cell disease
Preview
Source: Pharmaceutical Technology
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MHRA revokes Novartis’ Adakveo authorisation for sickle cell disease
Preview
Source: Pharmaceutical Technology
The company’s customer care team arrange the return of the product.
Clinicians and prescribers are advised to inform patients currently on Adakveo about the licence revocation and discuss alternative therapies.
The MHRA advised healthcare professionals to not begin treatment with Adakveo in new patients.
Patients who are prescribed Adakveo should not stop the treatment without consulting their healthcare professional.
In case of adverse reactions or queries about the medication, patients should seek medical attention.
The MHRA encouraged reporting of any suspected adverse reactions through the Yellow Card scheme.
A Dear Healthcare Professional Letter has been issued by Novartis to announce the revocation.
The latest development comes after the human medicines committee of the European Medicines Agency recommended revoking the marketing authorisation for Adakveo in sickle cell disease patients aged 16 years and above last year.
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