US regulators have expanded AstraZeneca's blockbuster Crestor for use in children and teenagers suffering from a genetic disease that causes high cholesterol.

The US Food and Drug Administration has approved Crestor (rosuvastatin) for paediatric patients aged 10-17 with heterozygous familial hypercholesterolemia. The decision was based on a supplemental New Drug Application which included data from the PLUTO study.

AstraZeneca said the PLUTO data will now be included on the drug’s label. However, Alex Gold, executive director of clinical development for Crestor in the USA, added that "while we believe it was important to investigate the use” of the treatment in these patients, “AstraZeneca does not plan to actively promote this indication”.

In July, the FDA had granted an additional six-month period of exclusivity for Crestor for its approved cholesterol and atherosclerosis indications until July 2016. That decision was based on the supplemental NDA and the completion of the PLUTO study “satisfied AstraZeneca’s commitment to the FDA to conduct a study evaluating the impact of Crestor on this paediatric population”.

HeFH affects 10 million people worldwide and is most commonly caused by a defect in the LDL-C receptor gene that leads to elevated levels of bad cholesterol, and an increased risk of early cardiovascular disease.

Meantime, AstraZeneca and partner Pozen have submitted a marketing authorisation application in the European Union for Vimovo, a combination of the former’s antiulcerant Nexium (esomeprazole) and the anti-inflammatory naproxen previously known as PN 400. The drug has been filed for the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing non-steroidal anti-inflammatory drug-associated gastric ulcers.

Vimovo was accepted for review by the FDA at the end of August.