Medical Device Daily

First came the announcement earlier this month that there would be a pen-like delivery device for insulin by Eli Lilly (Indianapolis) to help diabetics manage their disease to be introduced later this fall. Now, Abbott (Abbott Park, Illinois) has reported that the FDA has approved the Humira Pen, a new device for administering that company's Humira, which is approved to treat rheumatoid arthritis and psoriatic arthritis.

The pen is about 6-1/2 inches long with a cap that is easily pulled off. The patient pushes a button and waits five to 10 seconds for the device to inject the drug. A see-through indicator – once it is filled with yellow – indicates that the drug administration is complete. The device is manufactured by an unidentified third party.

“It's really all about patient convenience,” a spokeswoman for Abbott told Medical Device Daily. “If you think about it, even before we announced the pen device, there was sort of a spectrum of administration options for patients.”

Humira, she noted, was “the first pre-filled syringe” that was offered by Abbott to allow patients to inject Humira, a human monoclonal antibody, every other week. The pen follows the same dosing regimen of 40 mg every other week. And like the syringe, it has to be refrigerated.

“In an effort to constantly improve patient convenience and simplify things for patients, that's the rationale for why we embarked on developing this device,” she said, noting that such factors as space occupied for refrigeration storage factored into the design.

The spokeswoman said that patients were consulted during the design phase of the pen to ensure that such patients with rheumatoid arthritis and psoriatic arthritis, who often have swollen or damaged joints, could grasp the cap and fully operate the pen drug delivery device.

In Abbott's TOUCH trial (Trial of Usability in Clinical settings of Humira Autoinjector vs. Prefilled Syringe), which included 52 Humira prefilled syringe patients, about nine out of 10 preferred the new pen device, describing it as more convenient and easier to use. About eight out of 10 described the pen as being less painful.

The Abbott spokeswoman called the results “important.” And while she could not disclose adoption forecasts, she said the TOUCH trial results would indicate that there will be a preference by patients for the Humira pen over the syringe.

“Injectable medications are among the most effective treatments we have for RA and PsA, but nobody enjoys receiving an injection,” said Alan Kivitz, MD, a rheumatologist and founder of the Altoona Center for Clinical Research (Altoona, Pennsylvania). “The Humira Pen is an important advance because it offers people a convenient administration option to treat the disease.”

Abbott said that more than 5 million people worldwide have RA, an autoimmune disease that causes pain and stiffness in the joints of the hands, feet and wrists, and often leads to the destruction of joints.

The spokeswoman said that the Humira pen device also would be important for future indications for the drug now being studied by Abbott. For example, the company reported Phase III trial results on Friday of Humira in treating patients with ankylosing spondylitis, or arthritis of the spine, which typically affects younger patients who would particularly be looking for ease of drug administration, she said.

It's a device that may become ever more common.

At the 66th annual scientific sessions of the American Diabetes Association (Alexandria, Virginia) earlier this month June, Eli Lilly demonstrated its HumaPen Memoir, an electronic pen injection device with a feature that “remembers” previous doses of insulin (Medical Device Daily, June 12, 2006).

FDA-approved – and in use in Europe for several years – the HumaPen will get commercial rollout in the U.S. this fall, Lilly said.