FDA Approves Another Pricey Drug For Immune Condition GVHD

Stat: Kadmon Wins Approval For Drug To Treat Chronic Graft-Versus-Host Disease
Kadmon Pharmaceuticals won approval from the Food and Drug Administration on Friday to market a new treatment for chronic graft-versus-host disease — a debilitating immune condition that can affect as many as half of the blood cancer patients who undergo bone marrow transplants. The newly approved drug, called Rezurock, is Kadmon’s first internally developed medicine to reach the market. (Feuerstein, 7/19)

Stat: Cytokinetics Drug Improves Blood Flow In Patients With Form Of Heart Disease
Cytokinetics said Monday that its experimental drug demonstrated statistically significant improvements in blood flow for patients with an inherited form of heart disease — a result that compares favorably to a competing heart drug recently acquired by Bristol Myers Squibb. In a small, mid-stage clinical trial, 13 of 14 patients, or 93%, treated with a higher dose of the Cytokinetics drug, called CK-274, achieved improvement in blood flow to a target level where they no longer met the threshold for being diagnosed with their disease — obstructive hypertrophic cardiomyopathy, or HCM. No concerning or unexpected side effects were reported. (Feuerstein, 7/19)

Stat: Dutch Authorities Fine Drug Maker $23 Million Over Rare Disease Drug Pricing
Antitrust regulators in the Netherlands have fined a drug maker $23 million for years of “excessive” price hikes for a rare disease medicine, the latest instance in which European authorities cracked down on the pharmaceutical industry for harming consumers and taxpayers. In this case, the Netherlands Authority for Consumers and Markets cited Leadiant for a complicated set of maneuvers that saw prices rise from the equivalent of $54 in early 2009 to more than $16,000 by 2017 (see more here). The escalating cost caused what the agency called a “large public outcry” until a major medical center in Amsterdam eventually made its own, cheaper version available in 2020. (Silverman, 7/19)

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Stat: Scott Peters Collected Pharma Cash After Opposing Pelosi Drug Pricing Bill
The very next day after Rep. Scott Peters attempted to torpedo House Speaker Nancy Pelosi’s signature drug pricing bill by gathering a cadre of moderates to challenge the measure, pharmaceutical industry executives and lobbyists flooded his campaign with cash, according to campaign finance disclosures. Peters, a California Democrat, made waves in early May when he co-led a letter with nine other moderate Democrats taking a stand against the part of Pelosi’s painstakingly crafted drug pricing bill that would allow Medicare to negotiate drug prices — especially because Peters voted for the same bill in 2019 and 2020. Democrats have control of the House by a narrow margin, so the signatories’ opposition would essentially mean the bill can’t pass as is. Drug lobbyists largely viewed it as a death knell for the package. (Cohrs, 7/20)