Johnson & Johnson is celebrating the news that US regulators have given the go-ahead for the firm to market Concerta to treat adults with attention deficit hyperactivity disorder.

The US Food and Drug Administration has approved Concerta (extended-release methylphenidate) for adults aged 18 to 65 in doses of 18 to 72 mg daily. The drug has been available for children as young as six since August 2000 but "what we've seen in the growing body of knowledge on adult ADHD suggests a challenging burden of impairment in everyday functioning," said Janet Vergis, president of J&J unit McNeil Paediatrics.

ADHD is thought to affect about eight million, or one in 20, adults in the USA, J&J said, adding that it is associated with “academic underachievement, conduct problems, underemployment, motor vehicle safety and difficulties with personal relationships”. The approval will boost Concerta’s already-healthy sales which reached $290 million, up 15.1% in the first quarter.

Meantime, J&J unit Centocor has filed a Biologics License Application with the FDA for its much-touted new investigational anti-tumour necrosis factor therapy golimumab. The firm is looking to get the drug approved as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

The application is supported by data from five Phase III trials which have shown that patients treated with golimumab, a once-monthly injectable, experienced improvements in symptoms of RA as well as in physical function. One of the five studies, GO-AFTER, showed that patients with moderately-to-severely active RA previously treated with anti-TNF-alpha agents experienced significant improvements after treatment with the new drug.

The firm submitted an application with the European Medicines Agency in February for the same indications and if approved there, it will be marketed by Schering-Plough.