vladimirsorokin / iStockphoto.com
Amgen has filed a complaint against the US Food and Drug Administration (FDA) for not accepting its study reports and denying six months of paediatric exclusivity for its drug Sensipar (cinacalcet).
Sensipar is a management treatment for patients suffering from hyperparathyroidism.
According to the lawsuit, filed on Thursday, May 25 at the US District Court for the District of Columbia, Congress requires the FDA to grant six months of additional market exclusivity and patent protection to drugs for which paediatric studies were conducted in response to an FDA request for study reports.
This, Amgen added, is to encourage drug sponsors to develop critical information about the safety and efficacy of drugs.
The company claimed that the FDA is required to accept the study reports and grant exclusivity as long as the studies “fairly respond” to the FDA’s request.
Amgen said: “The studies need not demonstrate that the drugs are (or are not) actually safe and effective in children to warrant paediatric exclusivity, nor must they be adequate to support a paediatric indication on the drug product’s labelling, nor must the studies even ‘fully respond’ to the written request.”
The suing company also claimed that because its studies “fairly responded” to the written request, the FDA’s refusal to accept the study reports and its denial of paediatric exclusivity violate the Best Pharmaceuticals for Children Act.
The patent covering Sensipar, US number 6,011,068, is due to expire in March next year.
Amgen has asked the court for injunctive relief vacating the FDA’s decision to deny paediatric exclusivity, requiring the FDA to accept Amgen’s study reports.
Did you enjoy reading this story? Sign up to our free newsletters and get stories like this sent straight to your inbox.
Amgen, FDA, paediatric exclusivity, Sensipar, patent,