FDA approves Analog and Dipharma’s ANDA for nitisinone capsules

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules.

Nitisinone capsules are hydroxy-phenylpyruvate dioxygenase inhibitors which are used as first-line treatment for a rare condition, hereditary tyrosinemia type 1 (HT-1).

They are available in 2mg, 5mg and 10 mg dosages and are the generic equivalent of Swedish Orphan Biovitrum’s Orfadin.

Nitisinone capsules are indicated for the treatment of adult and paediatric patients with HT-1 in combination with dietary restriction of tyrosine and phenylalanine.

Some of the most common side effects of nitisinone include low platelet count, elevated tyrosine levels, eye pain, white or cloudy cornea from scarring, and pink eye.

Dipharma CEO Marc-Olivier Geinoz said: “For the first time, American HT-1 patients will have access to 20mg capsules, which are stable at room temperature for three years.

“This is the result of the collaboration between Dipharma and our American partner Analog Pharma, which achieved this milestone ahead of time: our next milestone for this year is to extend from two to three years and the stability at room temperature of the lower strength capsules as well.

“Dipharma is a pioneer in developing improved generic pharmaceutical products for rare diseases: our desire to innovate and our engagement do not stop, but every day we continue to seek new and better solutions for patients around the world.”