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Weekly Drug News Round Up - June 10, 2015

FDA Panel Recommends Approval of Cholesterol Drug Praluent

This new drug class is projected to have blockbuster potential of $10 billion or more Read More...

Sanofi and Regeneron Pharmaceutical’s Praluent (alirocumab), an injectable PCSK9 inhibitor drug shown to dramatically lower cholesterol, has been recommended for U.S. Food and Drug Administration (FDA) approval. Clinical data from the ODYSSEY Phase 3 trials show consistent, positive results in reducing LDL-C. The studied patient groups for alirocumab use include those with primary hypercholesterolemia or mixed dyslipidemia (including those with type 2 diabetes), and statin-intolerant patients. Common reported side effects included injection site reaction and pruritus (itching). Ongoing studies are assessing cardiovascular outcomes like stroke or heart attack. Final FDA decision for alirocumab is expected on or before July 24th.

Second PCSK9 Inhibitor Repatha Recommended by FDA Committee

Unlike Praluent, Repatha sponsor also seeking OK for the rare and serious homozygous familial high cholesterol Read More…

Amgen’s Repatha (evolocumab), an investigational cholesterol-lowering agent in the class known as PCSK9 inhibitors, has also been recommended for approval by an FDA Advisory Committee, one day after Praluent was also recommended. Studied uses include primary or mixed hyperlipidemia; statin intolerance or inappropriate for statin use; and homozygous familial hypercholesterolemia (HoFH) in patients 12 years and older. In Phase 3 trials evolocumab lowered LDL-C by over 60% across all study groups in 12- and 52-weeks studies; in HoFH, evolocumab reduced LDL-C by 31%. Common side effects included nasopharyngitis, respiratory tract infections, and back pain. FDA is expected to decide on evolocumab approval status by Aug 27th.

Statins Pose No Greater Risk for Memory Loss: Study

The study, which is observational, can’t prove cause and effect Read More...

In a week where PCSK9 cholesterol treatments occupy the headlines, good news about reported side effects with the statins surfaces. Previous studies suggest that HMG-CoA reductase inhibitors (statins) might cause short-term memory as a side effect. However, a large study published in JAMA Internal Medicine finds that statins are no worse for memory loss than other cholesterol-lowering medications. Researchers showed that, compared to nonusers, more patients taking statins or any other cholesterol-lowering medication reported memory loss in the 30 days after first taking the drugs. Statins include widely used medications such as Crestor (rosuvastatin), Lipitor (atorvastatin) and Zocor (simvastatin).

Pediatric Specific Formulation of Lopinavir/Ritonavir Approved

Worldwide, over 3 million children were living with HIV in 2013 and 240,000 children were newly infected Read More...

The US Food and Drug Administration (FDA) has approved lopinavir/ritonavir (LPV/r) 40mg/10 milligram (mg) oral pellets for pediatric specific treatment for infants. Lopinavir/ritonavir is a combination of two HIV protease inhibitors that works by stopping the HIV virus from multiplying. The pellets are produced by melt-extrusion technology and are enclosed in capsules. LPV/r oral pellets 40 mg/10 mg should be used in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing 5 kg and above and who can have semi-solid food. The pellets are sprinkled on infant cereal prior to oral administration.

One Dose of HPV Vaccine May Offer Needed Protection: Study

HPV can cause genital warts, cancer of the cervix, and various cancers of the vulva or vagina Read More...

In a new study published this week in The Lancet Oncology, researchers states that one dose of the human papillomavirus (HPV) vaccine Cervarix could prevent as many cases of cervical cancer as the current two- and three-dose schedules. This might be welcomed news for some parents, many of whom are shying away from the vaccine over suspected safety concerns. Cervarix vaccine is approved to prevent cervical cancer caused by HPV in girls and young women ages 10 through 25. The researchers found that one dose of Cervarix offered similar levels of protection over four years when compared to two and three doses.