ALK is working with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to help ease the shortage of adrenaline auto-injectors (AAIs) currently affecting allergy sufferers in the UK.
In response to a request from the Department of Health and Social Care, ALK has supplied additional stability data for its Jext AAI, enabling the MHRA to approve an extension of the use of specific batches of Jext that are currently in circulation by up to 4 months beyond the labelled expiry date.
AAIs are used for the emergency treatment of severe acute allergic reactions - also known as anaphylaxis - which can be triggered by exposure to certain foods, or by exposure to the venom from bee or wasp stings. The current shortage has been caused by supply issues involving another AAI product and is affecting several markets around the world. As a result, demand for alternative products such as Jext has increased greatly.
ALK estimates there are more than 100,000 Jext pens currently in circulation in the UK, which will soon expire. Extending the use of some of these beyond the labelled expiry date is expected to ease pressure on AAI demand by postponing the need for patients who already have pens from seeking to replace them while supplies remain limited.
Søren Niegel, Executive Vice President, Operations at ALK, said: "ALK is doing all it can to help address the current situation, but the long lead times associated with manufacturing medicines, together with the sheer size of the shortfall in the market, mean that we are unable to ramp up Jext production quickly enough to meet the patient demand. Nevertheless, we hope today's news will ease some of the pressure on prescribers and pharmacists, and will offer peace of mind to allergy sufferers who currently carry a Jext pen."
ALK is working with the Department of Health and Social Care to communicate with UK prescribers, pharmacists and patients about which specific batches of Jext are covered by the MHRA's approval. These are listed on www.jext.co.uk. Alternatively, anyone in the UK who wishes to check the status of their Jext pen can do so by consulting their doctor or pharmacist.
ALK-Abelló A/S
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014
About ALK
ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,300 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.
Attachment
- ALK_PressRelease_JextShelfLife_17Oct2018 (https://prlibrary-eu.nasdaq.com/Resource/Download/9ed88f45-6aed-4d1e-b517-760f37e216d8)
