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Weekly Drug News Round Up - July 29, 2015

Praluent: First Approval in New PCSK9 Inhibitor Class

Ongoing clinical trials, with results expected in 2017, are assessing cardiovascular outcomes like heart attack and stroke Read More...

Sanofi and Regeneron’s Praluent (alirocumab), the first in a potential blockbuster class of cholesterol-reducing agents known as PCSK9 inhibitors, was FDA-approved on Friday, July 24, 2015. Praluent use is approved in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as a heart attack or stroke, who require further LDL lowering. Praluent was evaluated in five placebo-controlled trials involving 2,476 patients. Participants taking Praluent had an average reduction in LDL cholesterol ranging from 36 to 59 percent, compared to placebo. The most common side effects have included nasopharyngitis, injection site reactions, and influenza. Serious allergic reactions were also reported.

AbbVie’s Technivie Wins Approval for Chronic Hepatitis C Infection

Technivie is the first all-oral treatment to be approved for chronic hepatitis C genotype 4 in the U.S. Read More...

Technivie (ombitasvir, paritaprevir and ritonavir) is an NS5A inhibitor, NS3/4A protease inhibitor, and CYP3A inhibitor fixed-dose combination indicated for use in combination with ribavirin for patients with genotype 4 chronic hepatitis C virus (HCV) infection. Technivie in combination with ribavirin is the first drug approved for genotype 4 HCV infections without the need for interferon. Technivie plus ribavirin was evaluated in 135 participants with chronic HCV genotype 4 infections without cirrhosis over 12 weeks. Results showed that 100 percent of the participants who received Technivie with ribavirin achieved a sustained virologic response (cure). Of those who received Technivie without ribavirin, 91 percent achieved sustained virologic response.

Odomzo By Novartis Okayed for Basal Cell Carcinoma

Odomzo is the second hedgehog pathway inhibitor approved for the treatment of basal cell carcinoma Read More…

The U.S. Food and Drug Administration (FDA) has approved Odomzo (sonidegib), an oral hedgehog pathway inhibitor for the treatment of locally advanced basal cell carcinoma that has returned after surgery or radiation, or for patients unable to have these treatments. By suppressing the hedgehog pathway, Odomzo may stop or reduce the growth of cancerous lesions. Odomzo joins Erivedge (vismodegib), approved in 2012, as the second hedgehog pathway inhibitor approved for basal cell carcinoma. Odomzo is a pill taken once a day, and carries a Boxed Warning stating that death or severe birth defects may occur in a developing fetus when administered to a pregnant woman.

FDA Approves Daklinza for Chronic Hepatitis C Genotype 3 Infections

Daklinza is the first drug approved to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin Read More...

Bristol-Myers Squibb has received FDA-approval for Daklinza (daclatasvir), an NS5A inhibitor used in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 3 infection. Roughly 10 percent of patients with HCV have genotype 3. In trials, patients received Daklinza 60 mg plus sofosbuvir (Sovaldi) 400 mg once daily for 12 weeks. Results showed that 98 percent of the treatment-naive participants with no liver cirrhosis and 58 percent of the treatment-naive participants with cirrhosis achieved sustained virologic response (cure). Of those who were treatment-experienced, 92 percent with no cirrhosis and 69 percent with cirrhosis achieved sustained virologic response.

Tramadol: Top 9 Facts You Need to Consider

Tramadol is a widely used pain medicine that has been linked with concerns of drug abuse and addiction Read More...

Tramadol, also known as Ultram, ConZip, Rybix ODT, or Ryzolt, is consistently ranked as one of the top 100 drugs used in the U.S. In 1995, tramadol was first approved by the FDA as a narcotic pain reliever thought to be associated with a lower risk of drug abuse. However, in 2012 it was reported that 3.2 million people in the U.S. aged 12 or older had abused tramadol. Emergency department visits due to tramadol abuse were also on the rise. Review this slideshow to learn more about this widely-prescribed painkiller - and see it's changing course over the years.