Although it may not be available until 2017, the FDA approved the use of etanercept-szzs for multiple autoimmune diseases…


Although it may not be available until 2017, the FDA approved the use of etanercept-szzs for multiple autoimmune diseases…
John Miller |
ZURICH (Reuters)—Novartis has won U.S. approval for a copy of Amgen’s blockbuster arthritis drug Enbrel, but the Swiss drugmaker’s bid to muscle in on the medicine’s $4.7 billion in annual U.S. revenue remains blocked by court battles. Novartis’s Sandoz unit said on Tuesday the U.S. Food and Drug Administration (FDA) approved Erelzi, its biosimilar copy…
Reuters Staff |
(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug etanercept (Enbrel). The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, a skin condition. The agency approved the drug as a biosimilar, meaning there is no…
This is the first clinical trial of an IL-6–targeted therapy in PsA. Clazakizumab may be an effective treatment option for musculoskeletal aspects of PsA, but because of the lack of a dose response in this study, further studies are required to confirm the appropriate dose. The safety profile is consistent with the pharmacology of IL-6 blockade and prior clinical experience with this antibody in rheumatoid arthritis…

FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…

Michelle Burda, MLS, & Terence Starz, MD |
A 52-year-old woman comes to the office complaining of a two-month history of pain and swelling in the small joints of her hands, feet and knees. She says, “Doctor, I’ve been searching the Internet, and I think I have rheumatoid arthritis. I have some questions for you.” The healthcare system in the U.S. is changing…
Gene Emery |
NEW YORK (Reuters Health) – The anti-inflammatory drug adalimumab can provide significant relief for about a quarter of people who suffer from a moderate-to-severe case of the chronic skin condition hidradenitis suppurativa, according to two 36-week trials. But the drug – which would cost over $104,000 per year for the weekly injections used in the…

In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…
Reuters Staff |
(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…

Donah Zack Crawford, MA, Jill Johnson, MD, Neal K. Moskowitz, MD, PhD, & James Udell, MD |
Ethical issues that arise in the average rheumatology practice and in clinical research are often straightforward. The AMA Code of Medical Ethics and the Office Practice and Procedures Manual offer useful information.1 In research, the Protocol and Investigators Agreement spells out who you can enroll and how the trial must be conducted. But still—even when…