Any remaining hopes for an expanded indication for Amarin’s Vascepa were largely dashed today by the FDA. Although it hasn’t yet rejected the proposed indication, the FDA today essentially overturned the foundation of the application, leaving little doubt as to the ultimate fate of the proposed new indication. As veteran biotechnology reporter Adam Feuerstein tweeted: “The…
FDA Approves First New Atherectomy Device In 20 Years
October 22, 2013 by Leave a Comment
The FDA today granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS was the first new coronary atherectomy system to receive FDA approval in 2 decades. The company said it would begin a controlled launch of the…
FDA Approves New Pulmonary Hypertension Drug From Actelion
October 18, 2013 by Leave a Comment
The FDA today approved macitentan (Opsumit, Actelion), a new oral endothelin-receptor antagonist that is an enhanced version of the company’s bosentan (Tracleer). The drug is indicated to delay disease progression in patients who have pulmonary arterial hypertension (WHO Group I). … Click here to read the full post on Forbes. …
Why The FDA Probably Won’t Approve An Expanded Indication For Amarin’s Vascepa
October 14, 2013 by Leave a Comment
On Wednesday an FDA advisory panel will consider an expanded indication for Amarin Pharmaceuticals’ Vascepa, an EPA fish oil product currently indicated only for people with severe hypertriglyceridemia (>500 mg/dl). The new indication would greatly expand the patient population eligible to receive Vascepa, from the relatively few people with severe hypertriglyceridemia to the many millions…
CardioMEMS Heart Failure Device Gets Mixed Reception From FDA Advisory Panel
October 9, 2013 by Leave a Comment
The FDA’s Circulatory System Devices Panel sent a mixed message to the FDA today about CardioMEMS Champion HF Pressure Measurement System. The small implantable device provides provides daily pulmonary artery pressure measurements to guide physicians in their treatment of patients with congestive heart failure. In December 2011 the same panel voted 9-1 that the device was safe, 7-3 that…
New Subcutaneous ICD Said To Pose ‘Existential Crisis’ For Older ICDs
August 26, 2013 by Leave a Comment
Last year the FDA approved Boston Scientific’s subcutaneous ICD, the first ICD that can defibrillate the heart without using leads threaded to the heart through the blood vessels. Those leads are the source of many sophisticated pacing features in today’s ICDs, but they are also the main source of ICD-related complications, and, in several well-publicized…
FDA Panel Recommends Approval For Pulmonary Hypertension Drug From Bayer
August 7, 2013 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended approval for Bayer’s new pulmonary hypertension drug, riociguat. The committee voted 11-0 in favor of approving the drug for two forms of pulmonary hypertension: pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTPH). Click here to read the full story on Forbes. …
Novel Pulmonary Hypertension Drug From Bayer Shows Modest Promise In Phase 3 Trials
July 24, 2013 by 1 Comment
A new drug appears to have promising– but not game-changing– effects in people with two forms of pulmonary hypertension. Riociguat, a soluble guanylate cyclase stimulator under development by Bayer, is thought to have vasodilating, antiproliferative and antifibrotic effects. Results of two phase 3 placebo-controlled trials were published today in the New England Journal of Medicine. CHEST-1 studied the clinical impact…
FDA Warns That Popular Blood Pressure Drug Can Cause Severe Diarrhea
July 3, 2013 by Leave a Comment
The FDA is warning that the widely-used antihypertensive agent olmesartan (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) may cause severe diarrhea. According to an FDA safety announcement, olmesartan “can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.” The warning is being added to…
FDA Turns Back New Indication For Rivaroxaban To Prevent Stent Thrombosis In ACS Patients
June 28, 2013 by Leave a Comment
Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application for rivaroxaban (Xarrelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the general use of rivaroxaban to…
Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’ Designation From FDA
June 27, 2013 by 1 Comment
Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the…
Roller Coaster Path To Approval For Eliquis Uncovered By FDA Documents
June 21, 2013 by Leave a Comment
After the presentation and publication of the pivotal ARISTOTLE trial, the novel anticoagulant apixaban (Eliquis, Pfizer and BristolMyers Squibb) was widely expected to be a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Ultimately approval of the drug was delayed for 9…
FDA Raises Concerns About The Cybersecurity Of Medical Devices
June 18, 2013 by Leave a Comment
The FDA has raised concerns about the vulnerability of medical devices to cyberattack. In one dramatic instance, reported by the Wall Street Journal, a VA catheterization laboratory in New Jersey was temporarily closed after malware infected the lab’s computer devices. … Halamka offered some additional perspective on the problem to the Washington Post: “There’s almost no medical…
FDA Advisory Panel Backs Looser Restrictions On Avandia
June 6, 2013 by Leave a Comment
After two days of deliberation an FDA advisory panel today recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions….
With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial
June 3, 2013 by Leave a Comment
The FDA today released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed…
Two FDA Officials Quarrel Over Safety Of Angiotensin Receptor Blockers
May 31, 2013 by 1 Comment
Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to a story by Thomas Burton in Friday’s Wall Street Journal. One official, Thomas Marciniak, contends that ARBs may increase the risk of cancer. Marciniak has been a vocal critic of FDA’s efforts to assess drug safety. In…
Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone
May 29, 2013 by Leave a Comment
An independent re-adjudication of the RECORD trial has confirmed the original findings of the trial, that rosiglitazone d0es not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary two-day FDA advisory committee meeting next…
Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting
May 24, 2013 by 1 Comment
Battle lines are being drawn two weeks before a highly unusual two-day FDA advisory committee meeting to discuss the contentious diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). This will be the second time an FDA panel has wrestled with the fate of the drug and expectations have been that the discussion will once again be heated. But at…
FDA Approves Combination Of Ezetimibe And Atorvastatin
May 3, 2013 by Leave a Comment
The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a…
Danish Study Finds No Increased CV Risk With Azithromycin In General Population
May 1, 2013 by Leave a Comment
A large observational study found no increased risk for cardiovascular events associated with azithromycin (Zithromax, Pfizer) in a general population of young and middle-age adults. In a paper published in the New England Journal of Medicine, Danish investigators report the results of a large national observational study comparing people who took azithromycin with matched controls…
Anticoagulation Update: New Agent For Urgent Anticoagulation Reversal, Pradaxa Label Revised
April 30, 2013 by 1 Comment
Here are two small but important changes in the anticoagulation field: FDA approves new product for urgent reversal of anticoagulation. … Pradaxa label gains boxed warning. … Click here to read the full story on Forbes. …
The FDA, Surrogate Endpoints, And Blood Pressure Drugs
April 22, 2013 by Leave a Comment
In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels– the surrogate endpoint– serious questions…
FDA Schedules Another 2 Day Avandia Advisory Panel
April 12, 2013 by Leave a Comment
Once again the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline) will be the subject of a 2 day FDA hearing. According to a meeting announcement scheduled to be published in the Federal Register on Monday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet on June 5 and June 6 to “discuss the results…
Once Again FDA Rejects Oral Treprostinil For Pulmonary Arterial Hypertension
March 25, 2013 by Leave a Comment
For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The manufacturer of the drug, United Therapeutics, said in a press release that it planned to discuss the decision with the FDA. “We remain confident that…
CHMP And FDA Diverge On Mipomersen And Rivaroxaban
March 22, 2013 by Leave a Comment
The US FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected— for the second time– an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the…
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