Drug major Lupin has launched Penicillamine tablets, used to treat Wilson’s disease, in the US market. The company has launched a generic product in the market after having received approval from the US and Drug Administration (U.S.FDA) earlier.
The Mumbai-based drug firm’s product is the generic equivalent of Mylan Specialty’s Depen tablets, which are indicated for the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.
As IQVIA MAT December 2020 data, Penicillamine tablets had estimated annual sales of USD 5 million in the US market.
Wilson disease is progressive in nature and is a rare genetic disorder characterized by excess copper stored in various body tissues, particularly the liver, brain, and corneas of the eyes.
If left untreated the disease may cause liver (hepatic) disease, central nervous system dysfunction, and death.
Serious long-term disability and life-threatening complications can be prevented if it is diagnosed early. Treatment is aimed at reducing the amount of copper that has accumulated in the body and maintaining normal copper levels thereafter.
Common signs of associated liver disease include a yellow discoloration (jaundice) of the skin, mucous membranes and the membranes (sclera) that line the eye, swelling (edema) of the legs and abdomen (ascites) due to abnormal retention of fluid, presence of abnormal blood vessels in the esophagus that may bleed (esophageal varices), a tendency for bruising and prolonged bleeding, and excessive tiredness (fatigue). Some individuals with Wilson disease may have only abnormalities of liver function test and may show no other symptoms until many years later.