Rheumatologists are accustomed to educating patients about medications—but biologic medications require some additional time and discussion. “Biologics are inherently more complex [than other medications], and there are multiple issues to consider before initiating treatment,” says K. “Kwas” Huston, MD, The Center for Rheumatic Disease, Kansas City, Mo. “This includes the patient’s disease activity, prior medications…
WASHINGTON (Reuters)—Two U.S. lawmakers have called on privately held Marathon Pharmaceuticals LLC to explain how it came to price its newly approved drug to treat Duchenne muscular dystrophy at $89,000 a year when patients have for decades been able to acquire it overseas for as little as $1,000. The drug, Emflaza, known generically as deflazacort,…
(Reuters)—U.S. Sen. Claire McCaskill (D-Mo.) on Thursday asked Kaleo Pharmaceuticals to justify the more than 550% surge in the price of its device to treat opioid overdoses, becoming the second senator to question Evzio’s $4,500 price tag. Evzio contains the overdose-reversing drug naloxone and can be used in emergencies by people without medical training. Privately…
A study showed that prior hospitalization and the use of multiple medications are risk factors for drug and drug–disease interactions…
The ACR has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development. Also, BI 695501, a biosimilar to Humira (adalimumab) made by Boehringer Ingelheim, has been accepted for regulatory review in both the U.S. and Europe. ACR Responds to FDA Biosimilar…
A recent analysis has examined the effectiveness of baricitinib in treating RA patients who suffer from comorbidities and the effect of concomitant use of steroids. Baricitinib proved effective, particularly in patients who had exposure to cDMARDs and corticosteroids…
FDA Review of Baricitinib Delayed The U.S. Food and Drug Administration (FDA) has extended the review period for baricitinib, an investigational medication for treating moderate to severe rheumatoid arthritis (RA).1 Baricitinib is a once-daily oral Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The New Drug Application (NDA) for baricitinib…
EULAR has updated its recommendations for the management of early arthritis, outlining aspects of diagnosis and drug treatments…
GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab…
The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…