The FDA Advisory Committee Voted 22-1 In Favor of Approval of Its
Melanoma Immunotherapy T-VEC
Yesterday’s Prohost’s intelligent prediction that the FDA committee will vote in favor of approving Amgen’s melanoma drug T-VEC has proven to be correct. “Amgen (AMGN) cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval” That’s what the independent advisory panel selected by the U.S. Food and Drug Administration said Today.
As a matter of fact, the panel voted 22-1 supporting an approval for T–VEC (talimogene laherparepvec), which comprises an engineered virus that kills cancer cells when injected into tumors and also works systemically to prime the immune system to attack the disease.
The recommendation comes two days after FDA staff expressed concerns over the design and results of a key study on T-VEC and raised questions over the interpretation of data from a late-stage study. The FDA reviewers had also said that it was unclear if the treatment improved overall survival of patients.
Weighing what the reviewers said prior to the meeting, we did not really feel that the regulatory agency meant to discourage the advisory committee from approving the drug, The observations were just like all other observations the FDA reviewers usually express before the advisory meetings who would vote in favor of, or against the approval of investigational drugs. On Wednesday, i.e., the same day of the meeting, Amgen said that T-VEC was more effective in melanoma patients whose cancer had not spread to internal organs.
The U.S. is expecting more than 70,000 cases of melanoma to be diagnosed in the United States this year, according to the National Cancer Institute. Read our article posted on www.Prohostbiotech.com under TODAY’S HIGHLIGHTS On Tuesday April 28.
Other Exciting News About Amgen Recent Past And Upcoming Approvals
Amgen Drug Corlanor is Approved
For Chronic Heart Failure
Recently, the FDA approved its drug Corlanor® (ivabradine) to reduce the risk of hospitalization for Worsening heart failure in patients with chronic heart failure. We published this news on Prohost Website Under TODAY’S HIGHLIGHTS on Friday April 17, 2015. April.
In this news, we learned that the FDA has granted approval of Amgen’s drug Corlanor® (ivabradine), an oral medication indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≤35 percent, who are in sinus rhythm with resting heart rate ≥70 beats per minute (bpm) and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use.
Corlanor is contraindicated in patients with acute decompensated heart failure, blood pressure < 90/50 mmHg, sick sinus syndrome, sinoatrial block, 3rd degree AV block (unless a functioning demand pacemaker is present), a resting heart rate < 60 bpm prior to treatment, severe hepatic impairment, pacemaker dependence (heart rate imposed exclusively by the pacemaker) and concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors.
An Upcoming Approval Of Amgen’s Drug Repatha™
Another Cardiovascular Savior
The FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC will review data that support Amgen’s Biologics License Application (BLA) of Repatha™ (evolocumab for High cholesterol on June 10, 2015.
Repatha™ is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or from the blood.
The data the EMDAC will review emanates from clinical trials conducted on approximately 6,800 patients, including more than 4,500 patients with high cholesterol in ten Phase 3 trials.
The Phase 3 studies have evaluated the safety and efficacy of Repatha™ on the following patients with elevated cholesterol levels:
– Patients on statins with or without other lipid-lowering therapies;
– Patients who cannot tolerate statins;
– patients with heterozygous familial hypercholesterolemia (HeFH) and;
– Patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder.
A Prescription Drug User Fee Act (PDUFA) target action date is set for of Aug. 27, 2015.
Repatha™ (evolocumab) is a fully human monoclonal antibody that inhibits (PCSK9) – a protein that targets LDL receptors for degradation and thereby reduces the liver’s ability to remove LDL-C, from the blood. By binding to PCSK9, the drug prevents this protein from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.
The FDA has provisionally approved the trade name Repatha™
Amgen’s cardiovascular pipeline consists of several investigational molecules. The investigational and recently approved therapeutics address a number of important unmet patients needs, such as high cholesterol and heart failure (see category of patients cited above who were recruited into the Repatha™ trials.
Prohost expects Rapatha’s BLA to be recommended for approval by the committee at the June 10 meeting and the FDA approval around August 27, or probably before that date. The drug is novel and has proven to improve cardiovascular diseases that very high level of LDL cholesterol plays a role in their etiologies.
We believe that most, if not all analysts expect the drug to become a best selling drug.
The same can also be said about a similar drug developed by Regeneron (REGN), which we expect it would be granted approved around 6 months after the approval of Amgen’s drug Rapatha.
What we cited in this article represents a fraction of what Amgen’s product pipeline and its projects and strategies are expected to add to the firm’s value. Sooner, or later, the fair value of the firm will have to be reflected on the firm’s market capitalization. The fair values of firm are based on facts, in contrast with the oversold and overbought values that are based solely on mere speculations.
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