Amgen, Inc. (NASDAQ:AMGN) has announced that it has received European Commission approval for expanded use of Mimpara® (Cinacalcet) to treat secondary hyperparathyroidism (HPT) in children above 3 years old.
The European Commission authorization means the company now has marketing authority for pediatric use of Mimpara. The expanded use authorization will allow for treatment in children 3 years and older who have end‑stage renal disease (ESRD) but whose secondary HTP is not effectively controlled through standard care therapy.
“Secondary HPT is a serious and complex condition, and there are currently limited treatment options available for pediatric patients living with this disease. We are pleased with today’s approval and the opportunity to provide patients and health care providers with an important therapy,” stated Dr. Sean E. Harper, the executive VP of Research and Development at Amgen.
Amgen was awarded the approval for Mimpara based on studies that were initiated in 2007 to examine the use of the treatment in pediatric patients with secondary HTP who have limited options for treatment. The European Commission’s approval will allow the company to carry out centralized marketing with uniform labels in 28 countries that are part of the EU. Liechtenstein and Norway who are members of the European Economic Area (EEA) are expected to make corresponding decisions based on the decision made by the European Commission.
The announcement marks a huge win for Amgen especially considering that it has been carrying out research for Mimpara for about 10 years. The firm is also confident that the treatment will be a significant offering that will improve the lives of pediatric patients living with HPT. The fact that there have been limited treatment options means Mimpara will rapidly gain traction as the latest and most effective treatment for the health condition.
The treatment is also expected to perform well in terms of revenue, considering that there is very little competition in the target market. Amgen did not reveal its plans for a global rollout of the drug, though that will have to involve review by other regulatory bodies.
Amgen stock closed the latest trading session on Thursday at $177.77.