Epix submits appeal to FDA for Vasovist
Epix Pharmaceuticals (Cambridge, Massachusetts), a developer of pharmaceuticals for magnetic resonance imaging (MRI) which recently announced a definitive agreement to merge with Predix Pharmaceuticals (Lexington, Massachusetts), reported that it has submitted a formal appeal to the FDA asking the FDA to approve the company's blood-pool imaging agent, Vasovist.
The company submitted the appeal to the Office of New Drugs of the FDA and has asked that an Advisory Committee be utilized as part of the appeal process. The company expects that the Office of New Drugs will respond to the company's submission within about 30 days, although any decision could be delayed if the Office of New Drugs grants the company's request for an Advisory Committee.
"The submission of this appeal is the next step in a long process and represents a substantial undertaking for our company and underscores our confidence in the clinical profile and benefits of Vasovist," said Dr. Andrew Uprichard, Epix president and COO. "We are hopeful that we will have the opportunity to present the data from our four completed Phase III trials, as well as other data collected on Vasovist, to an Advisory Committee as part of the appeal process, and are continuing preparations accordingly."
Vasovist, Epix's lead product candidate, is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through magnetic resonance angiography.
Cigna to cover Cambridge Heart's MTWA test
Cambridge Heart (Bedford, Massachusetts) said that Cigna HealthCare, a provider of healthcare benefits covering more than 12 million Americans, has revised its coverage position on Microvolt T Wave Alternans (MTWA) testing, agreeing to make it a covered benefit for its beneficiaries. The coverage position now states: "CIGNA HealthCare covers microvolt T-wave alternans testing as a method to identify risk of ventricular arrhythmias and sudden cardiac death for patients who meet criteria for implantable cardioverter defibrillator placement."
"We are very pleased that after reviewing all of the published literature on Cambridge Heart's system … Cigna has recognized the benefit that MTWA can provide to their beneficiaries," said David Chazanovitz, president and CEO of Cambridge Heart. "The utilization of our diagnostic test in patients eligible for implantable defibrillator therapy is becoming more and more important as physicians work to provide the most appropriate individualized care for their patients."
Cambridge Heart makes products for the noninvasive diagnosis of cardiac disease. The Cambridge Heart Microvolt T-Wave Alternans Test measures T-wave alternans, extremely subtle beat-to-beat fluctuations in a person's heartbeat. Extensive clinical research has shown that patients with symptoms of or, who are at risk of, life threatening arrhythmias who test positive for T-wave alternans are at significant risk for subsequent sudden cardiac events including sudden death, while those who test negative are at minimal risk.