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

UsernamePublicRestriction
UsernamePublicRestriction

ROFERON, INTRON A APPROVED FOR AIDS-RELATED KAPOSI's SARCOMA IN "SELECT" PATIENT GROUP; TREATMENT RECOMMENDED FOR NON-IMMUNE-COMPROMISED PATIENTS

Executive Summary

Schering-Plough's Intron A and Roche's Roferon recombinant alfa interferon products are indicated for a "select" group of AIDS-related Kaposi's sarcoma patients. FDA and the two companies announced approval of the new indication for alfa interferon in separate Nov. 21 press releases. "Studies have demonstrated a greater likelihood of response to Intron A therapy in patients who are without systemic symptoms, who have limited lymphadenopathy and who have a relatively intact immune system," Schering's labeling states. Roche noted three criteria in determining whether an AIDS patient might be eligible for interferon therapy: no history of opportunistic infection; no B symptoms, i.e. night sweats, body weight loss and fever; and a T4 cell count of 400 or greater. FDA's simultaneous approval of the two alfa interferon products for the new use indicates that the agency continues to consider Intron A and Roferon as essentially equivalent products. Initial approval, for treatment of hairy cell leukemia, was granted to both firms on the same day in 1986. Since then, however, Schering has obtained an approval for genital warts, an indication that Roche did not pursue. Roche submitted its AIDS-related Kaposi's sarcoma PLA (product license application) for Roferon in July 1987. Approximately 350 AIDS patients with Kaposi's sarcoma were studied in the U.S., Roche noted. Schering said it began data submissions for Intron A as early as 1983, with the final submission as recently as this year. The company reported that in its studies, 58% of asymptomatic patients with T4 counts of more than 200 showed a clinical response. The recommended dosage of Intron A for the new indication is 30 mil. IU three times a week administered subcutaneously or intramuscularly. "When disease stablilization or a response to treatment occurs, treatment should continue until there is no further evidence of tumor or until discontinuation is required by evidence of a severe opportunistic infection or adverse effect," labeling states. For Roferon, the recommended dose is 36 mil. IU daily for 10-12 weeks administered as an intramuscular or subcutaneous injection. Labeling for both interferon products advises the measurement of lesions and blood counts prior to initiation of therapy, as well as their monitoring during therapy to determine response or disease stabilization. However, optimum duration of therapy has not yet been determined. "Treatment should continue until there is no further evidence of tumor or until discontinuation is required by evidence of a severe opportunistic infection or adverse effect," the Intron A and Roferon labels state. Both Roche and Schering have pledged to cap annual patient costs of alfa interferon for Kaposi's sarcoma at $9,800. Roche estimates that at the same unit cost charged for the hairy cell leukemia treatment, the treatment regimen for Kaposi's sarcoma would cost between $35,000-$50,000 per year. Both companies also have ongoing indigent programs under which drugs are supplied free-of-charge to those that cannot afford them. The U.S. patient population for AIDS-related Kaposi's sarcoma is relatively small. The Centers for Disease Control reports 7,063 cases between June 1981 and November 1988. The actual number may be higher, since these include only those with Kaposi's sarcoma at the time HIV infection was diagnosed. Through the first 10 months of this year, 1,716 cases were reported. FDA highlighted the AIDS drug approval in a separate release announcing the approvals. "The clinical trials that we reviewed at FDA demonstrated that interferon induced remission and prolonged survival in those patients who were responsive to therapy," FDA Commissioner Frank Young remarked.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS014702

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel