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Published on : Jul 28, 2017

Amgen Inc has recently announced that the U.S. FDA has granted priority review to its request to add to the label of one of its costly injectable cholesterol medicine Repatha additional heart safety information. The FDA will finalize by December 02, 2017 whether or not to allow the company to add data from a clinical trial that states that the drug also helps in significantly cutting the risk of stroke, heart attack and death in addition to helping bring down the level of bad LDL cholesterol in the blood, Amgen said in a publication.

Until the heart safety data is officially included in the drug’s prescribing information, Amgen cannot promote it. Thus, updating the label with the data will play a critical role in unlocking the true monitory potential, which could translate into multibillion dollars. Repatha has witnessed improving but weak sales ever since it was approved nearly two years ago on the basis of its capability to lower LDL bad cholesterol. The drug was able to gather nearly US$83 mn from global sales.

Owing to the high cost of the drug, pharmacy managers and insurers have made it difficult for patients to access the drug, with as many as 75% of all prescriptions written for the drug being denied. The company has said that post rebates and discounts, the annual cost of Repatha falls between US$7,700 to US$11,200. With more clinical evidence regarding the injectable biotech medicine’s benefits in more than just lowering down the LDL level is being considered crucial for payers to start authorizing prescriptions, leading to wider use.