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FDA sets records in 2018 in new drug approvals

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A view of the US Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland. Reuters

WASHINGTON (Xinhua) – The United States Food and Drug Administration (FDA) set a record this year in new drug approvals, giving green light to multiple innovative drugs to fight cancers and HIV.

FDA approved 59 new molecular entities in 2018, setting a two-decade record, according to the database of the agency.

“Some of those previous records were set in years when there were a lot of drugs that critics bemoaned were me-too medicines: novel chemical entities that all addressed the same common, therapeutic targets,” said FDA director Scott Gottlieb.

“The kinds of innovation we’re seeing now are more targeted, more fashioned against significant medical needs, and far more effective,” said Mr Gottlieb in a statement.

Meanwhile, FDA approved 86 orphan drugs this year, also making a record. The orphan drugs are those intended for rare diseases that affect fewer than 200,000 people in the United States.

FDA also announced it had approved and tentatively approved more generic drugs in fiscal year 2018 (from October 2017 to September 2018) than in any other year prior, seeing a total of 971 approvals, 781 final approvals and 190 tentative approvals.

Among the new approved drugs, 17 had been approved to treat cancers, among which seven drugs are designed to treat leukemia. Patients with certain kinds of lung cancer, breast cancer, lymphoma and melanoma also saw new drugs, according to FDA.

FDA approved this year a breakthrough drug in treating multiple cancers called Vitrakvi, which is designed to fight a specific genetic mutation in some forms of cancer.

Another breakthrough is the approval for three anti-HIV drugs, respectively Biktarvy, Trogarzo and Pifeltro.

FDA approved three drugs for the preventive treatment of migraine, a common disease but with limited curing options.

It also approved Xofluza for the treatment of acute uncomplicated influenza, making it the first new antiviral flu treatment with a novel mechanism of action approved in US in nearly 20 years.

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