Takeda Wins U.S. FDA Approval for New Way to Adminster Velcade to Patients

Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, won U.S. approval to administer its cancer medicine Velcade under the skin, a form of injection that causes fewer patients to experience the drug’s side effects.

The Food and Drug Administration cleared the treatment for multiple myeloma, a type of blood cancer, the Osaka, Japan-based company said in a statement. The new method reduced the number of patients who experienced severe nerve damage, Takeda said.

Velcade was approved by the U.S. regulator in 2003 as an intravenous injection and generated $594 million in sales for the year ended March 31, according to data compiled by Bloomberg. With fewer side effects, the under-the-skin injection will probably become the preferred method of administration, said Deborah Dunsire, chief executive officer of Takeda’s Millennium Pharmaceuticals.

“We’ll have more patients that can stay on Velcade longer,” Dunsire said in an interview. “That could be a reason for sales to expand.”

Takeda rose 1.1 percent to 3,280 yen as of 10:23 a.m. in Tokyo trading, while the Topix Index was little changed. The shares have dropped 18 percent in the past 12 months.

Of 222 relapsed multiple myeloma patients in a Takeda- sponsored clinical trial, 38 percent who got the drug subcutaneously experienced the nerve damage called peripheral neuropathy, compared with 53 percent who received it through an intravenous injection, according to a Dec. 7, 2010, statement from the company.

Severe Side Effects

The subcutaneous administration also decreased Velcade’s association with severe adverse side effects, which led fewer patients to discontinue therapy. Of patients receiving the medicine just below the skin’s surface, 57 percent experienced severe side effects and 22 percent ended treatment, compared with 70 percent who received the drug intravenously and 27 percent who stopped using it, according to the 2010 statement.

The treatment worked consistently when given through either means, it said.

The new method of delivering the drug was an accidental discovery by a nurse in France, who was working with an elderly patient and couldn’t easily find a vein for an intravenous injection, said Dunsire.

“For reasons I don’t quite know, the nurse decided to administer the drug subcutaneously,” she said. “She reported this to the supervising physician, who immediately checked on the patient, who actually did extremely well, and was able to then continue receiving Velcade subcutaneously.”

One benefit of the new delivery method is that medical assistants, who aren’t allowed to give intravenous injections, can administer the drug under the skin, she said.

“We do anticipate that the vast majority ultimately will switch over,” Dunsire said.

New Brunswick, New Jersey-based Johnson & Johnson markets the drug outside the U.S.

To contact the reporters on this story: Anna Edney in Washington at aedney@bloomberg.net; Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net

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