Daily Newsletter

03 October 2023

Daily Newsletter

03 October 2023

FDA approves Empaveli injector for PNH patients

The device allows patients to administer their therapy subcutaneously from home or in the clinic to increase flexibility in their daily lives.

Jenna Philpott October 02 2023

The US Food and Drug Administration (FDA) has approved Apellis Pharmaceuticals’  Empaveli injector (Enfuse) for the subcutaneous delivery of Empaveli (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria (PNH).

PNH is a rare disease that is characterised by red blood cells breaking apart prematurely, causing symptoms such as haemolytic anaemia and shortness of breath.

The injector is a single-use, wearable device that allows patients to self-administer 20ml of subcutaneous therapy, enabling at-home treatment.

Empaveli generated $65.1m in sales last year, according to Apellis’ 2022 annual report. It is not the only treatment for PNH that is delivered by intravenous infusion (IV). Ultomiris (ravulizumab) marketed by Alexion Pharmaceuticals generated $1.96bn in sales last year, according to AstraZeneca’s 2022 annual report. Ultomiris must be administered by a healthcare provider, unlike Empaveli, which can now be administered at home by the patient themselves.

According to GlobalData, Empaveli is forecast to exceed $2bn by 2030.

The injector is developed in collaboration with Enable Injections, a Cincinnati, US-based developer of drug delivery systems.  

Chief technology officer and executive vice-president of business development at Enable Injections Matthew Huddleston said: “The Empaveli Injector is the first purely mechanical, large-volume, on-body subcutaneous drug delivery device.”

Patient consumerism is gaining momentum

Healthcare is evolving from a ‘doctor knows best’ mentality to a patient-doctor relationship where the patient takes an active role in making informed healthcare decisions. Patients can have more of a say in their healthcare decisions because they have access to information through various means, including the literature, the internet, and more recently, different types of connected medical devices. With the rise of mobile health applications, wearable technologies, and telemedicine, patients are well-situated to gain medical information, and ultimately make the best choices for their health.

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