FDA Approves First PCSK9 Inhibitor, New Drug for Basal Cell Carcinoma, and More
Praluent – High Cholesterol
The FDA has approved Praluent (alirocumab) for the treatment of patients with high cholesterol. Praluent is the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.1
The PCSK9 inhibitor is approved for use in addition to diet and statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease such as heart attacks and strokes.
The drug works by targeting the PCSK9 protein—a substance that reduces the number of receptors on the liver that remove LDL cholesterol from the blood.
The safety and efficacy of Praluent were evaluated in 5 placebo-controlled trials involving 2476 patients with HeFH or at high risk for heart attack or stroke.
Overall, participants assigned to Praluent saw reductions in LDL cholesterol levels of between 36% and 59% compared to placebo.
The most common side effects reported were itching, swelling, pain, and bruising at the site of injection, nasopharyngitis, and flu.
Odomzo – Locally Advanced Basal Cell Carcinoma
The FDA has approved Odomzo (sonidegib) for the treatment of patients with basal cell carcinoma that has recurred following surgery or radiation therapy.2
Odomzo, a once-daily pill, works by inhibiting the Hedgehog molecular pathway, suppressing the growth of basal cell carcinoma.
The safety and efficacy of Odomzo was tested in a multi-center, double-blind clinical trial involving 66 patients with locally advanced basal cell carcinoma randomly assigned to 200 mg of Odomzo each day 128 patients assigned 800 mg of Odomzo each day.
Overall, 58% of participants treated with 200 mg of Odomzo saw shrinkage of their tumors, an effect that lasted between 1.9 and 18.6 months. Rates of shrinkage were similar in the 800 mg group, although side effects were more frequently reported.
Side effects include muscle spasms, hair loss, dysgeusia, fatigue, nausea, muscle pain, abdominal pain, headache, vomiting, a pruritus.
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Bio-Rad BioPlex 2200 HIV Ag-AB assay – HIV diagnosis
The FDA has approved the Bio-Rad BioPlex 2200 HIV Ag-AB assay, a test that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen using human serum or plasma samples.3
Note: HIV-1 and HIV-2 are similar but distinct viruses. HIV-1 is responsible for the majority of HIV infections globally, while HIV-2 is predominantly found in West Africa.
The BioPlex 2200 is intended for the diagnosis of HIV infection in adults and children 2 years or older, and is safe for use in women who are pregnant. It may also be used to screen organ donors for HIV in cases in which blood specimens are taken while the donor is still alive. It is not intended for use in screening blood or plasma donors.
Along with differentiating between HIV-1 and -2, the BioPlex 2200 can also be used to differentiate between acute and established HIV infection.
—Michael Potts
References:
- FDA. FDA approves Praluent to treat certain patients with high cholesterol [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455883.htm.
- FDA. FDA approves new treatment for most common form of advanced skin cancer [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455862.htm.
- FDA. FDA approves diagnostic test to differentiate between types of HIV infection [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455813.htm.