![]() ![]() market armed with a variety of patents and intellectual property protections that stave off competition and allow drugmakers to set prices as they see fit. The company also continues to invest in research and development as well as clinical studies for the drug to reach more patients, Carmichael said. patients taking the drug as approved by the FDA are covered by commercial or government insurance. Mary Carmichael, a spokesperson for its manufacturer, Novartis, said Zolgensma has treated more than 3,000 patients globally and nearly all U.S. For example, Zolgensma, a one-time treatment for spinal muscular atrophy, carries a $2.25 million price tag. ![]() Often, drugs granted exclusivity are among the highest priced in the U.S. Circuit Court of Appeals denied a motion in early 2022, the FDA stopped reviewing applications for certain drugs or handing out exclusivity, agency spokesperson April Grant said. When a drugmaker wins approval for an orphan drug, the company is entitled to seven years of exclusive rights to the marketplace, which means the FDA won’t approve another company’s application for a competitive drug for the same use during that period.īut after the 11th U.S. court ruling involving Firdapse, the drug Wilkinson needs.įirdapse was approved in 2018 by the FDA as an “orphan drug,” a designation that rewards drug companies for developing treatments for rare diseases. The FDA made its latest move in the tug of war in late January by saying it would largely ignore a U.S. supports pharmaceutical companies and their research. Wilkinson, like millions of other people with rare diseases nationwide, is caught up in an ongoing legal and political debate about how the U.S. “Who can afford that?” said the 91-year-old, who lives in Rochester, Minnesota. ![]() ![]() But now, her Medicare insurance is shelling out about $40,000 for a one-month supply of the drug, and she fears she’ll be slammed with a $9,000 copayment. A prescription drug that helps Lore Wilkinson walk and talk despite a rare muscle disease cost her so little for more than a decade that she didn’t even use her insurance to pay for it. ![]()
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