As a shortage of epinephrine pens continues to grip the U.K., authorities have agreed to extend the expiration date on a second injector to help ease the situation.
ALK today said the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is currently deciding which batches of its Jext pens can have the expiration extended by four months while more are being manufactured. The company said it has provided additional stability data to the agency to help with the processes.
ALK estimated there are more than 100,000 Jext pens currently in circulation in the U.K. that will soon expire.
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“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,” Søren Niegel, ALK executive VP operations said in a statement. “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.”
U.K. authorities late last month did the same thing for Mylan's 0.3 mg auto-injector EpiPens, supplies of which have been short around the globe since manufacturing issues were discovered by the FDA at the Pfizer plant which manufactures them for Mylan. The MHRA also has put restrictions on who can be prescribed pens until the shortage is resolved.
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The FDA announced similar measures in August for Mylan EpiPen’s as the back-to-school rush exacerbated an ongoing shortage of injectors in the U.S. The agency extended the expiration date of specific lots of 0.3-mg products by four months beyond the labeled expiration date. That is beyond the approved 20-month shelf life. The FDA in August also approved the first official generic of the EpiPen from Teva, but that product won’t be available to consumers for some weeks.
Spot shortages of Mylan’s EpiPens developed last year when a Pfizer subsidiary that makes them for Mylan had delays tied to FDA concerns about manufacturing. Pfizer has said it is working hard to deal with issues and ramp up supplies.