Novartis extends Symjepi launch to US pharmacies amid shortage of EpiPen

Novartis' Sandoz unit said Tuesday that it would make adult and paediatric doses of Symjepi, its generic pre-filled epinephrine injections, immediately available in local pharmacies across the US, as a shortage of Mylan's emergency allergy medicine EpiPen (epinephrine) continues due to manufacturing problems. Symjepi, which was previously only accessible in hospitals, "will help address critical impact of ongoing epinephrine auto-injector shortages for the one in 50 Americans at risk for anaphylaxis," Novartis said. 

Pfizer's Meridian Medical Technologies unit, which produces all EpiPens sold globally at a single facility near St. Louis, Missouri, has been hit by a series of manufacturing problems and the company recently stated that it expects more supply shortages in the months ahead. In March, Pfizer disclosed that it had received a request for documents as part of a US probe into quality issues involving the manufacture of auto-injectors at the site.

Adamis Pharmaceuticals gained US approval for Symjepi to treat type I allergic reactions in 2017, with Novartis acquiring US rights to the therapy last year. 

Novartis priced Symjepi at $250 for a twin pack, putting it at a $50 discount to Mylan's authorised generic version of EpiPen. Sandoz launched Symjepi in January in the institutional setting with plans to eventually introduce the treatment to the retail market. 

Sandoz president Carol Lynch commented "patients and healthcare professionals are trying to navigate this critical shortage of self-injectable epinephrine products." She added that "our collaboration with retail partners will enable patients and their caregivers to conveniently access Symjepi, a cost-effective treatment option with a compact and user-friendly design."

Meanwhile, Teva, which priced its epinephrine auto-injector at parity with Mylan's authorised EpiPen generic, has captured an 18% market share as of late June, according to Leerink analysts. Teva has said that it expects its product will capture a quarter of the US market by the end of the year.

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