Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

Squibb's Capoten (captcaptopril) is first line therapy for hypertension in patients with normal renal function, according to the drug's newly revised labeling. FDA approved new labeling for the drug, including an indication covering all degrees of hypertension, on July 1. Captopril "may be used as initial therapy for patients with normal renal function, in whom the risk [of neutropenia/agranulocytosis] is relatively low," the package insert states (for text of the new indication, see box below). FDA expanded the indication for captopril after a nearly three-year supplemental NDA review. The agency based its decision on clinical studies which found that the risk of neutropenia in the normal renal group was "one patient out of over 8,600 exposed." The drug's labeling initially limited use to last line treatment because the extent of the neutropenia/agranulocytosis risk was unknown. The principal population at risk, the studies found, was the group of renally impaired patients with collagen vascular diseases. According to the new Warnings section, in the clinical trials, neutropenia occurred in 3.7% of those patients. In patients with "some degree" of renal failure, but no collagen vascular disease, "the risk of neutropenia in clinical trials was about one per 500, a frequency of over 15 times that for uncomplicated hypertension," the insert says. For those populations, captopril treatment is reserved for individuals who develop "unacceptable side effects" to other drugs or "fail to respond satisfactorily to drug combinations." The insert notes that, "in general, neutrophils returned to normal in about two weeks after captopril was discontinued, and serious infections were limited to clinically complex patients. About 13% of the cases of neutropenia have ended fatally, but almost all fatalities were in patients with serious illness, having collagen vascular disease, renal failure, heart failure or immunosuppressant therapy, or a combination of these complicating factors." In a July 3 press release announcing the apoval, Squibb said: "This significant broadening of the indicated usage for Capoten means that the drug may be prescribed as first-step therapy for the great majority of hypertensive patients." Based on Capoten's accelerating sales, use for less severe antihypertensive indications has already begun to be reflected in current medical practice. Pharmaceutical Data Services recently reported that Capoten sales in 1985 could exceed $110 mil. CAPOTEN's REVISED HYPERTENSION INDICATION [Reprinted from FDA's revised package insert, approved July 1] CAPOTEN (captopril) is indicated for the treatment of hypertension. In using CAPOTEN, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS). CAPTOEN may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with imparied renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. CAPOTEN is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captropril and thiazides are approximately additive.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts