American College of Physicians: Internal Medicine — Doctors for Adults ®


Therapy briefs

From the March ACP Observer, copyright 2006 by the American College of Physicians.

First inhalable insulin gets FDA approval

The Food and Drug Administration (FDA) has approved the first inhalable form of insulin to treat diabetes, marking the first alternative to injections since the hormone was discovered in the 1920s.

The inhaled insulin, to be marketed as Exubera by Pfizer Inc., will not entirely replace the need for injections. According to an FDA news release, patients with type 1 diabetes can add inhaled insulin to longer-acting insulins as a substitute for short-acting insulin taken with meals. For those with type 2 diabetes, inhaled insulin can be used alone or with longer-acting insulins. Patients with diabetes still will have to prick their finger to test their blood-sugar levels.

As with the injectable version, low blood sugar is a side effect of inhaled insulin. Other side effects include cough, shortness of breath, sore throat and dry mouth.

The FDA also said that diabetics who have smoked within the past six months should not use inhaled insulin and that it is not recommended for patients with asthma, bronchitis or emphysema. Physicians should perform baseline tests for lung function, the FDA release said, before beginning treatment and every six to 12 months thereafter.

Pfizer has agreed to perform continuing long-term safety studies in patients with underlying lung disease.

The FDA release is online.

FDA approves new drug for chronic angina

The FDA recently approved a new drug for treating chronic angina, the first such drug to go on the market in more than a decade.

Ranolazine, marketed as Ranexa by CV Therapeutics, is a molecular entity recommended for patients who have not responded to other antianginal drugs, including long-acting nitrates, calcium channel blockers and beta-blockers, said an FDA news release. The new drug is not recommended for all patients because it affects electrical conduction in the heart.

Many of the 6.8 million Americans diagnosed with angina each year respond to other treatments, including surgery and other drugs, according to the release. However, some continue to suffer episodes of chest pain, pressure or discomfort, limiting their activities.

The approval is based on clinical trial results showing that patients who did not respond to other antianginal drugs experienced a reduction in angina attacks and improvement in exercise stamina after taking ranolazine, the FDA release said. The agency noted that the drug appeared to be less effective in women than in men and that side effects included dizziness, headache, constipation and nausea.

The FDA release is online.

New drug approved to treat two cancers

The FDA recently approved a targeted drug to treat a rare stomach cancer and advanced kidney cancer. It is the first time the agency has approved a cancer drug for two uses.

Sunitinib (Sutent), marketed by Pfizer, was approved to treat gastrointestinal stromal tumor (GIST) in patients whose disease has progressed or who cannot tolerate the current standard therapy, imatinib mesylate, according to an FDA news release. Studies showed that the drug delayed the growth of tumors in GIST patients, with a median progression time of 27 weeks for patients treated with sunitinib vs. six weeks for patients not receiving the drug.

In studies on renal cell carcinoma, sunitinib shrank some tumors by more than 50%, with an overall response rate between 26% and 37% in patients whose tumors had progressed after standard treatment, the release said. That provides new hope for patients with advanced kidney cancer for whom chemotherapy and radiation often have little effect. Only a small percentage of patients respond to interleukin-2 and interferon.

The drug's most common side effects include diarrhea, skin discoloration, mouth irritation, weakness and altered taste.

The FDA release is online.

Home infusion device approved for immune disorders

The FDA has approved a new device to help people with rare immune disorders self-administer therapy at home.

The approval of Vivaglobin, made by Germany's ZLB Behring GmbH, marks the first approval of an immune globulin product for subcutaneous injection, according to an FDA news release. The device allows people with primary immune deficiency diseases to self-administer replacement antibodies on a weekly basis using an infusion pump.

The device provides an alternative for patients with rare immune disorders who need chronic intravenous infusions. Primary immune deficiency diseases are rare genetic disorders that affect about 50,000 Americans. Side effects include moderate injection site reactions, including swelling and itching. Contraindications are similar to those with other immune globulin products.

The FDA release is online.


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