NPS Pharmaceuticals Inc.’s hormone drug, Natpara, has received authorization for sale from the U.S. Food and Drug Administration. Natpara is aimed at treating hypoparathyroidism, which is a rare kind of a hormone disorder. The approval validates a Shire Plc’s stake as it had recently agreed to take over NPS. The acquisition deal between NPS and Shire will be a $5.2 billion deal.
NPS seeks to launch Natpapa as a potential therapy for hypoparathyroidism, a disease condition in which the parathyroid gland fails to secrete required amounts of parathyroid hormone. The hormone is responsible for the calcium regulation in the body. It works with Vitamin D to perform the function.
Common effects of low levels of the parathyroid hormone is a tingling sensation in the fingers and toes, fatigue, muscle spasms, muscle aches, dry skin, hair loss, memory problems and mood swings. The disease can be caused because of surgery or congenital disorders. Natpara is essentially a bioengineered variation of the natural hormone itself.
According to NPS, around 180,000 people suffer from hypoparathyroidism worldwide. The New Jersey-based pharmaceutical company also claims that in 40% of the total number of cases, the presently available treatment options fail to control the condition. Essentially, the available treatments offer patients high doses of Vitamin D, as well as calcium. Citing this data, NPS said that it plans to make this set of patients as the chief receptors of the new treatment. In the U.S., approximately 20,000 people fall under NPS target category.
Late-stage trials of the drug proved the efficacy of the drug by reducing the needs for external supply of Vitamin D and calcium in the patients by almost 50%.
Although the disease is a rare type of a hormone disorder but it is expected that the drug will generate annual sales of $542 million by 2019.