Another indication for Humira
pharmafile | November 28, 2012 | News story | Sales and Marketing | Abbott, Crohn's, EU, Humira
Abbott’s Humira has received its ninth indication in Europe with approval to treat youngsters suffering from the inflammatory bowel disease Crohn’s.
The European Commission says Humira (adalimumab) can be used to treat pediatric patients aged 6 to 17 years-old with severe active Crohn’s if conventional therapy is not appropriate.
The disease is commonly treated with primary nutrition therapy, a corticosteroid and an immunomodulator but some children are intolerant to, or have contraindications for these.
Abbott argues that the TNF blocker addresses an unmet need and another of Humira’s selling points is that it can be administered at home.
Pediatric Crohn’s affects up to 200,000 children worldwide, and involves inflammation of the end of the small intestine and the beginning of the large intestine. As well as causing severe pain and discomfort, its effects in children can include the delaying of puberty and retarding of growth.
European regulators based approval on the Phase III IMAgINE 1 trial, which looked at two different dosing strategies in this patient group.
“With this approval, these young patients and their care providers may now have access to a therapy that can help manage their disease and be administered at home,” said John Medich, Abbott’s divisional vice president, clinical development, immunology.
In addition to the nine indications in Europe, Humira has seven in the US – but the drug’s US patent expires in just four years.
Add-ons such as the new approval are important because it is still a key growth driver for Abbott, accounting for $2.3 billion of overall sales of $9.8 billion in the third quarter of this year alone.
Adam Hill
Related Content
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Sarclisa recommended for EU approval in newly diagnosed multiple myeloma
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi’s …
EU approval granted for rare kidney disease treatment
The EU has granted marketing authorisation (MA) for Filspari – CSL Vifor and Travere Therapeutics’ …
