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Drug Updates

Subcategories:AnalgesicsBiologics/DMARDs

Biosimilars to Raise Unique Questions

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Rheumatologists are accustomed to educating patients about medications, but biologic medications—and now biosimilars—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. The first FDA-approved biosimilar to become…

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Tips, Resources to Help Rheumatologists Educate Patients on Biologics and Biosimilars

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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…

Two U.S. Lawmakers Probe Marathon over $89,000 Drug Price

Reuters Staff  |  

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,…

U.S. Senators Question Kaleo’s $4,500 tag on Opioid Overdose Treatment

Ankur Banerjee  |  

(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…

Biosimilar Update: ACR Says FDA Draft Guidance Is Promising & Biosimilar to Humira (Adalimumab) Enters Regulatory Review

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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has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development.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…

FDA Update: FDA Delays Baricitinib Review & Removes Bupropion & Varenicline Warnings

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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…

Rheumatology Drug Updates: Giant Cell Arteritis Relapse Possible if Tocilizumab Discontinued; Plus Updates on Rituximab, Etanercept

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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…