FDA panel recommends costly new cholesterol drug New drug could help patients wh
ID: 331187 • Letter: F
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FDA panel recommends costly new cholesterol drug
New drug could help patients who cannot take statins
10:00 AM - November 6, 2016
An FDA advisory panel on Tuesday voted 13-3 to recommend that the agency approve Praluent, an injectable cholesterol-lowering drug, though the panel also said more data are needed to determine the drug's ability to reduce strokes and heart attacks.
Praluent details
Sanofi and Regeneron Pharmaceuticals are the manufacturers of Praluent, known generically as alirocumab. The treatment is part of a new class of medicines, often called PCSK9 inhibitors, thought to have the potential to change the course of cardiovascular treatment and result in billions of dollars in revenue for drug companies. Such drugs block the PCSK9 protein, which affects the body's ability to clear "bad cholesterol." Drugs in the class could be beneficial for individuals who cannot take or do not benefit from treatment with statins.
If FDA approves Praluent, it would be the first treatment in the drug class to gain approval, according to the Wall Street Journal. The FDA panel is considering another PCSK9 inhibitor, Repatha by Amgen, on Wednesday.
Most studies have shown that Praluent lowered patients' cholesterol by about 40% to 60%. Patients who took Praluent showed a slightly greater incidence of memory impairment than those in comparison groups. However, the side effect "was not characterized as serious" among the eight patients who experienced such a reaction, according to James Smith, deputy director of the FDA's division of metabolism and endocrinology products. In addition, 2.5% of Praluent patients experienced liver problems, compared with 1.8% of patients taking a placebo.
Panel discussion
The panel considered whether there was sufficient evidence to recommend the drug be approved before it underwent testing in large clinical trials.Several panelists voiced concern about whether completed trials were large enough to draw conclusions about safety.
In addition, several panelists said that the drug should be used only by patients with abnormally high levels of cholesterol caused by a certain inherited disorder, according toAP/Modern Healthcare.
Philip Sanger of Stanford University, who voted to approve the drug, said, "I personally fall on the side of having optimism, but I need to see the cardiovascular outcome study to know."
Michele Orzsa, the panel's consumer representative, said, "I am really only comfortable with the risk-benefit equation in that population."
Cost concerns
Some critics have raised concerns over the cost of PCSK9 inhibitors, USA Today reports. The drugs could cost $10,000 per year.
The costs, combined with the potential number of patients, could be a source of concern for insurers, as well as others who would have to pay for the drugs, according to the Times. If FDA grants broad approval for Praluent, about 11 million U.S. residents could be eligible to take the drug, according to Sanofi estimates (AP/Modern Healthcare, 6/9 [subscription required]; Burton, Wall Street Journal, 6/9 [subscription required]; Firth, MedPage Today, 6/9; Kolata,New York Times, 6/9; Szabo/Winter, USA Today, 6/9).
Question: How should the company market this drug to increase sales?
Explanation / Answer
As mentioned in the case, the new drug Praluent has been approved by the FDA. It is also mentioned that it has numerous benefits which can be passed on to improve the health of the consumers and patients. To effectively market such a product, the company should do the following activities:
• Focus strongly on the points where it shows the benefits it is having in cholesterol patients.
• Show how different the product is form others
• Launch the medicine in such a way that the medicine is a category creator not another addition to existing categories.
Traditionally all pharma drugs have been using the push strategy to sell the medicine, but in this case, we can use the pull strategy to market the product. There are multiple benefits of using the medicine such as:
• Lowering the cholesterol level significantly
• Less side effects of using medicine
• Cost covered under insurance
In lieu of the above points, it can easy for the patient to understand the benefit of such medicine. To promote the medicine, they have to start print media ads to advocate the benefit of using this medicine. Once the consumers are aware of the benefits, the next target should be the ensuring that the supply chain is able to properly deal with the demands. The distributers and retailers should be compensated enough to keep the drug available at all locations. Sanofi and Regeneron can also start using their tie ups with network hospitals to promote the medicine. But all this should be done from a pull perspective rather than pushing the product on the consumer. If the consumers can see the long term benefits of the product, the popularity and demand of the same will rise significantly.
In order to deploy such an effective plan, Sanofi and Regeneron should do the following:
• Identify the product strengths and ensure the marketing mix is focused on the same
• The idea of helping of patient and doctor should be highlighted throughout the campaigns
• Start considering the digital supply chain as a major main stream distribution channel
• Ensure proper feedback is captured for patients specially who show signs of liver problems
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