US FDA Grants Approval to Cholesterol Drug Praluent
Friday saw the US Food and Drug Administration approve a drug that lowers artery-clogging cholesterol more than older drugs that have been prescribed for long. This drug named Praluent, is manufactured by Sanofi SA and Regeneron Pharmaceuticals Inc.
Friday's decision by the FDA followed a decision by the European Commission that came earlier this week, wherein Amgen Inc's cholesterol lowering drug, Repatha was granted approval. However, FDA's approval limits Praluent's use to patients in whom heart disease either is a hereditary condition or developed later on.
Praluent and Repatha have been considered the first major advance in treatment since the introduction of statin drugs more than 20 years ago and analysts expect them to generate billions in their sales. They are basically PCSK9 inhibitors, the first in a new class of biotech medications that use a novel approach to lower bad or LDL, cholesterol.
The FDA approved Praluent for two groups of patients at highest risk of heart problems. The first being patients with abnormally high LDL cholesterol caused by an inherited condition, while the second including patients with high LDL cholesterol and a history of heart attack, stroke, chest pain and related conditions.
However, the prohibitive factor for the drug is its cost. While existing generic statin pills are available at very reasonable rates, Praluent is a highly expensive, injectable drug for one of the most common medical conditions. Therefore, it is drawing flak from various quarters. The drug's $40-a-day price is even higher than many analyst predictions. This means an annual cost of $14,600, which makes it out of the reach of majority of people.
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