Analog Pharma and Dipharma announce US FDA approval of abbreviated new drug application (ANDA) of generic Nitisinone capsules (temperature stable)
Rosemont, PA and Chiasso, Switzerland, June 21st, 2022 – Analog Pharma (“Analog”) and Dipharma S.A. (“Dipharma”) today announced that their nitisinone abbreviated new drug application (ANDA) has received final approval from the U.S. Food and Drug Administration. Nitisinone Capsules is a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum’s Orfadin®, available in 2, 5 and 10 mg capsules.
Nitisinone capsules are a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Analog expects to distribute the product through specialty pharmacies beginning in Q3 2022.
“We are enthusiastic of this approval by the FDA” said Mr. Marc-Olivier Geinoz, CEO of Dipharma. “Our nitisinone capsules, which were successfully launched in Europe 4 years ago, will soon also be available for the patients in the USA through our partner Analog Pharma. Dipharma is a pioneer in developing improved generic pharmaceutical products for rare metabolic diseases. Our nitisinone is bioequivalent to Orfadin® but is more stable: it can be stored at room temperature for 2 years, which provides a convenience for the patients and is more environment-friendly across the supply-chain as it does not need to be refrigerated. Furthermore, we will soon add the 20 mg capsule to our range of products, as well as submit data to support the extension of the shelf life to 3 years at room temperature.”
Tanya Carro, Executive Vice President, Analog Pharma, commented, “I look forward to a fruitful collaboration with Dipharma to bring American patients with Hereditary Tyrosinemia type-1 (HT-1) another treatment option. This additional product to our portfolio demonstrates our commitment to ensuring that patients get the medications they need at a price they can afford.”
Nitisinone is used to treat adult and pediatric patients with a confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restrictions. Since its use as the first-line treatment of HT-1, nitisinone has replaced liver transplantation for this rare condition. Dipharma’s Nitisinone Capsules has already been approved and launched in most European countries.