Humira adalimumab regulatory update

The U.K.’s NICE issued a final appraisal determination (FAD) recommending 3 mAbs against tumor necrosis factor (TNF) alpha to treat moderately to severely active ulcerative colitis (UC): Remicade infliximab from Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) and Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.); Humira adalimumab from AbbVie and Eisai; and Simponi golimumab from J&J and Merck. Specifically, the drugs are recommended in adults whose disease has responded inadequately to conventional therapy, including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate or have medical contraindications for such therapies -- their approved indications.

Remicade is also approved for the indication in patients ages 6-17 years, for which NICE also recommended the drug. The drugs should be given until treatment failure or until 12 months after starting treatment -- whichever is shorter. The recommendation for Simponi is contingent on Merck providing the 100 mg dose at the same cost as the 50 mg dose under a patient access scheme. ...