On August 1st 2020 AxxessBio and Cycle Pharmaceuticals entered into an exclusive agreement for the distribution of NITYR® (nitisinone) tablets in Singapore, Thailand, Brunei, Philippines, Macau and Hong Kong. NITYR® does not have marketing authorization in these territories however it is being made available through Name Patient Programs. These programs differ country to country.
NITYR® (nitisinone) Tablets are indicated for the treatment of patients with Hereditary Tyrosinemia Type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
HT-1 is an ultra – rare genetic metabolic disease characterized by lack of an enzyme which is needed for the final break down of the amino acid tyrosine. Failure to properly break down tyrosine leads to abnormal accumulation of tyrosine and its metabolites in the liver, potentially resulting in severe liver disease. Tyrosine may also accumulate in the kidneys and central nervous system.
Symptoms and physical findings associated with HT-1 appear in the first months of life and include failure to gain weight and grow at the expected rate (failure to thrive), fever, diarrhoea, vomiting, an abnormally enlarged liver (hepatomegaly), and yellowing of the skin and the whites of the eyes (jaundice). HT-1 may progress to more serious complications such as severe liver disease, cirrhosis, and hepatocarcinoma if left untreated. Treatment with nitisinone and a low-tyrosine diet should begin as soon as possible after the diagnosis is confirmed.
Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering best-in-class drug treatments and services to the under-served rare disease patient community. Cycle focuses on rare metabolic and neurological genetic conditions. Cycle is headquartered in Cambridge, UK and has offices in Boston, Mass. (USA). For more information, please visit www.cyclepharma.com
NITYR® (nitisinone) Tablets is approved in the USA, Australia, New Zealand, the Kingdom of Saudi Arabia, the Kingdom of Morocco, and Israel in 2, 5 and 10 mg strengths and in the EU and Chile in 10 mg strength. Cycle Pharmaceuticals’ nitisinone products are also approved under a different name, NITISINONE TABLETS, in Canada in 2, 5, and 10 mg strengths. Registration conditions differ internationally. NITYR® (nitisinone) Tablets, USA Prescribing Information is available at: www.nityr.us/PI
NITYR® (nitisinone) is a registered trademark of Cycle Pharmaceuticals Limited in the United Kingdom, Europe and the United States.
