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arthritis

AbbVie granted EU marketing authorisation for new arthritis drug

AbbVie have announced that the European Commission (EC) have granted marketing authorisation for RINVOQ (upadacitnib). It’s a daily selective reversible JAK inhibitor for the treatment of adults with moderate to severe rheumatoid arthritis, who are intolerant of other similar drugs.

It may be used as a monotherapy or in combination with methotrexate.

The EC authorisation of RINVOQ is based on data from a Phase 3 trial which saw 4,400 patients participate.

Europe approves first subcutaneous version of biosimilar infliximab

The European Commission has chosen to authorise Celltrion Healthcare’s Remsima SC, a biosimilar of infliximab and the first subcutaneous formulation of the therapy, it has emerged.

The therapy was approved in combination with methotrexate (MTX) for the treatment of active rheumatoid arthritis in adult patients who have seen inadequate response with disease-modifying anti-rheumatic drugs (DMARDs), including MTX, and additionally in patients with severe, active and progressive forms of the disease who have not been previously treated with MTX or other DMARDs.

Eli Lilly's Taltz shows superiority over AbbVie's Humira

A study has found that Eli Lilly’s Taltz (ixekizumab) met the primary, and all secondary endpoints, in patients with active psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drug (DMARD)-naïve when compared to AbbVie's Humira.

 The Phase IIIb/IV SPIRIT-H2H study, 566 patients with active PsA demonstrates Taltz’s superiority over the world’s bestselling drug.

Top Ten most popular articles on Pharmafile.com this week

The year seems like it's running away as we come to the end of April. It's been a more tense period than usual in the industry as the Takeda-Shire saga has unfolded, and unsurprisingly, news related to the merger has dominated the headlines. That's reflected in our most popular articles this week, with three stories related to the tale.

Lilly dumps Hanmi’s rheumatoid arthritis med

Eli Lilly and Hanmi signed an exclusive licensing and collaboration agreement to develop the Bruton’s tyrosine kinase (BTK) inhibitor, HM71224, for the treatment of various autoimmune and other diseases in 2015.

The deal was worth a potential $690 million in total but that hasn’t stopped Lilly showing every sign of ducking out of the deal early.

Lilly gets second shot at application for ‘blockbuster’ arthritis drug

Earlier this year, Eli Lilly was on the receiving end of one of the most surprising setbacks in recent times for its rheumatoid arthritis drug, baricitinib. The FDA rejected the drug and asked Lilly for more data, after it pointed out instances of blood clotting in trial data.

Existing arthritis drug could save thousands in blood cancer treatment

Findings by researchers at the University of Sheffield have indicated that thousands of pounds could be saved in blood cancer treatment by tapping into the unexplored properties of methotrexate, a drug traditionally used to treat inflammatory diseases like rheumatoid arthritis, psoriasis and Crohn’s disease.

Sanofi and Regeneron score FDA approval for arthritis

The FDA has awarded Sanofi and Regeneron’s Kevzara (sarilumab) approval for the treatment of moderate to severely active rheumatoid arthritis (RA) in patients who have not responded to prior therapy.   

Kevzara is co-developed by Sanofi Genzyme and Regeneron; both will split revenue from sales of the drug. The drug was originally knocked back by the FDA in October due to ‘deficiencies’ in its manufacturing process at a company facility in Normandy, France. These issues have since been rectified.

Roche says Phase III trials for giant cell arteritis drug met primary endpoint

Cancer drugmaker Roche (SIX: ROG) said late stage trials for its drug to treat giant cell arteritis (GCA) met its primary endpoint. 

The company said the Phase III study for Actemra/RoActemra (tocilizumab) initially combined with a six month steroid (glucocorticoid) regimen, showed more effective sustained remission through one year. 

NICE recommends four treatments for arthritis in children

BMS's Orencia was recommended in draft guidance

 

UK Healthcare guidance body NICE has today published final draft guidance recommending four drugs for the treatment of juvenile ideopathic arthritis (JIA) in children and young people.

NICE has provisionally recommended Orencia (abatacept, Bristol-Myers Squibb), Humira (adalimumab), AbbVie), Enbrel (etanercept, Pfizer) and RoActemra (tocilizumab, Roche), within their marketing authorisations, for the condition.

 

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