Please login to the form below

Not currently logged in
Email:
Password:

Roche submits Actemra for RA in US

Roche submits a biologics license application to the FDA seeking US marketing approval for Actemra for the treatment of moderate-to-severe rheumatoid arthritis in adults

Swiss pharmaceutical company Roche has submitted a biologics license application (BLA) to the FDA seeking US marketing approval for Actemra (tocilizumab) for the treatment of moderate-to-severe rheumatoid arthritis (RA) in adults.

Actemra is the first humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA.

Research suggests that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints and relieve certain systemic effects of RA.

The BLA submission is based on results from five international phase III studies, which tested Actemra as a monotherapy or in combination with disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate, on 4,000 patients in 40 countries.

Findings showed that Actemra significantly reduced the signs and symptoms of RA, as measured by ACR and disease activity score (DAS) remission rates, compared with DMARD therapies alone.

In addition, patients who had previously failed anti-tumour necrosis factor (anti-TNF) treatments also showed significant improvement in signs and symptoms of RA after treatment.

One of the phase III trials evaluating Actemra in RA is an ongoing two-year study and is expected to report one-year data evaluating the effect of the drug on the inhibition of structural damage in 2008.

William M Burns, CEO of the pharmaceuticals division at Roche, said: "The filing for Actemra in the US is an important milestone, and brings us another step closer to making this therapy available to the millions of patients in the who suffer from the pain and debilitating effects of rheumatoid arthritis."

Roche will file a Marketing Authorisation Application (MAA) for the product with the European Medicines Agency (EMEA) in early December 2007.

WestLB analysts expect Actemra to generate sales of at least CHF 2bn (USD 1.8bn) and placed an "Add" rating on Roche, whose shares rose sharply on the news, up 2.2 per cent at CHF 204.20 (USD 183.57).

30th September 2008

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Iguazu

Iguazu Ltd is a digital healthcare agency, delivering tactical and innovative solutions. WHAT WE DO We are Closed Loop Marketing...

Latest intelligence

#DemandDiversity: For International Women's Day, we ask... why do women often suffer from more side effects than men?
Women are largely prescribed exactly the same treatment regimens as men, with no account for the underlying differences in physiology and drug metabolism between the sexes....
Good design saves lives
Good design and creative thinking are essential if we are to improve on existing problems in new ways, which is why design and creativity within healthcare is vital. Health is...
Why you must understand the pricing of patient recruitment companies
Recruiting a diverse range of patients and engaging with them for your clinical trial isn’t an easy task, which means you might turn to patient recruitment companies, like us, who...

Infographics