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Drugmakers, Regulators Rush to End Shortage of Leukemia Therapy

Hospira Inc., Fresenius SE and Boehringer Ingelheim GmbH are racing to restore U.S. supplies of a leukemia drug while regulators look to imports to meet patient demand.

The Food and Drug Administration is working with the three companies to restore manufacturing levels for the medicine, cytarabine, and has found an overseas drugmaker willing to temporarily import the injections, Shelly Burgess, an agency spokeswoman, said yesterday. She declined to name the company because the product hasn’t been approved.

Difficulties obtaining the drug’s main ingredient and preventing crystals of dried medicine from forming in vials have limited the availability of cytarabine since last year. The drug is a “critical component” of treatment for patients with acute myeloid leukemia and acute lymphocytic leukemia, according to the Leukemia & Lymphoma Society in White Plains, New York.

“Without it, most patients die,” Louis DeGennaro, the organization’s chief mission officer, said yesterday in a telephone interview. “There’s really no substitute for cytarabine in those chemotherapy regimes.”

Acute myeloid leukemia causes aggressive growth of certain white blood cells in bone marrow. The American Cancer Society estimated that the disease was diagnosed in 12,330 patients last year and led to 8,950 deaths. An estimated 5,330 people were diagnosed last year with acute lymphocytic leukemia, which affects a different type of white blood cell.

Manufacturing Priority

Hospira re-entered the market in March after fixing the crystallization issue and has made the manufacture of cytarabine a priority ahead of other products, Daniel Rosenberg, a spokesman for the Lake Forest, Illinois-based company, said in a telephone interview. Hospira controlled about one-third of the market before the shortage and aims to supply more patients as production increases “in the next weeks and months,” he said.

The APP Pharmaceuticals division of Bad Homburg, Germany-based Fresenius plans to resume distribution of cytarabine vials next week, Debra Lynn Ross, a company spokeswoman, said yesterday in an e-mail. Earlier batches were recalled because of customer complaints over crystals forming in the vials.

Bedford Labs, a division of closely held Boehringer in Ingelheim, Germany, plans to release 82,000 vials in the next few weeks, said Jason Kurtz, a company spokesman. The company provided more than half of the cytarabine on the market at the end of last year and exhausted its supply when competitors faced delays, Kurtz said. Bedford hasn’t seen any issues with crystallization or ingredient supply, he said.

Seeking Importer

The FDA began looking for a company to import the medicine when the shortage worsened in January. It took longer than usual to find a company willing to import the drug, the FDA’s Burgess said.

“If all goes as planned this will be continuing to improve with resolution anticipated soon,” she said in an e-mail. “We do finally have a firm willing and able to do the importation, and we are proceeding with this since we believe it’s important to have a back-up.”

The agency temporarily allowed APP to import the anesthesia drug propofol last year when there was a shortage. Imported products are reviewed to assure safety, effectiveness and quality, Burgess said.

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