The pharmaceutical company that earlier refused to give its experimental drug to Josh Hardy, a seven-year-old cancer survivor currently battling with adenovirus infection spreading in his body, has finally decided to donate the drug to the dying kid.
Chimerix, a Durham-based drug company, has earlier declined requests to give the $50K brincidofovir to Josh, who needed the antiviral drug to clear the adenovirus in his body. Josh's family, however, didn't easily give up and instead launched a campaign asking supporters to help them pressure the company into giving Josh the drug that could save his life.
With the campaign and news of the dying boy who was denied access to a life-saving drug gaining ground, Chimerix's refusal to donate brincidofovir has drawn national attention and even criticisms. On Tuesday, the company has apparently given in to public pressure as it announced it will finally give the antiviral drug to the young patient saying it will provide the brincidofovir drug to Josh Hardy as the first patient of a pilot trial for the drug.
"Chimerix, Inc. (Nasdaq:CMRX) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) for the immediate initiation of a pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients," the company said in a statement. "Josh Hardy's story brought to public attention the often-devastating impact of adenovirus infection, and helped accelerate a discussion between the FDA and Chimerix regarding the need for additional clinical development to assess brincidofovir's potential in adenovirus infection. This study is expected to begin with Josh Hardy as the first patient enrolled onWednesday, March 12, 2014."
In an earlier statement posted on its website, Chimerix said it restricts access to its experimental drug because making it available outside of trials can slow down or derail its approval. The company, however, has reached an agreement with the Food and Drug Administration (FDA) to initiate a pilot trial for brincidofovir that Josh will be part of.
"We are pleased to be providing access to brincidofovir in a manner consistent with our focus on progressing clinical development toward a potential regulatory approval that would make it widely available to patients who might benefit from its use," said Hervé Momméja-Marin, Vice President of Clinical Research at Chimerix. "We are grateful to the FDA for their continuous guidance and assistance in expediting brincidofovir's development path forward."
Josh's family expressed delight over the company's decision. "It was wonderful," Todd Hardy, Josh's father said. "Truly wonderful. It was overwhelming."
