Generic drug for allergies excites

FDA approval of generic version of EpiPen has sufferers ‘buzzing’

The New Zealand allergy community is “buzzing” at the prospects of cheaper life-saving adrenaline autoinjectors after the approval of a generic version in the United States.

The devices contain adrenaline, which is injected through a spring-loaded needle into the muscle of the leg, and are used to treat potentially life-threatening allergic reactions.

There had been outrage at rising costs of the EpiPen brand in the United States, after Mylan Pharmaceuticals bought the rights to the anaphylaxis treatment in 2007, boosting the price from US$93 ($139.29) for two injectors to more than US$600.

In August, the US Food and Drug Administration ap- proved the first generic version of EpiPen and EpiPen Jr auto-injector, produced by Teva Pharmaceuticals USA.

The FDA said it would give patients a lower-cost option and help protect against potential drug shortages.

While there had been no application yet to Medsafe in New Zealand to register it here, Allergy New Zealand chief executive Mark Dixon said the potential was “exciting”.

Mylan EpiPens were not subsidised by Pharmac, and could cost between $120-$250 each, Dixon said. They could be used only once, and expired after a year.

“As you can imagine a lot of families currently simply can’t afford them. Allergy families carry the full burden as there is no government support.”

Pharmac currently funded adrenaline in an ampoule that could be used with a needle and syringe by people experi- encing anaphylaxis. The ampoules cost about $1 each.

However, this was often challenging for some sufferers and their supporters to administer.

“They also have to know how to assemble and inject it, which can be difficult, especially in an emergency.”

Dixon said adrenaline autoinjectors had been on Pharmac’s waiting list for more than 13 years, with budget concerns being the major factor.

If the pens were subsidised the number of people using them could increase dramatically. Dixon said the estimated $5 cost of manufacturing gen- eric adrenaline auto-injectors could make them substantially more affordable for those in need. “A new generic supplier in the world market changes everything. The community is buzzing.”

Pharmac director of operations Lisa Williams said although it was in close contact with potential suppliers, it had not received an application for funding from the new generic supplier.

“We continue to be in close contact with all potential suppliers of adrenaline autoinjectors with the aim of negotiating an affordable long-term funding agreement.”