Abbott Laboratories announced Tuesday that its antibioticBiaxin (clarithromycin) has been approved for the treatment ofdisseminated mycobacterium avium complex (MAC).

Abbott (NYSE:ABT) of Abbott Park, Ill., said Biaxin isrecommended as the primary agent in combination therapy forthe treatment of MAC. The company said the drug is the first tobe approved for the treatment of disseminated MAC. AdriaLaboratories' Mycobutin (rifabutin) was approved in December1992 for prevention of MAC in patients with advanced HIV.

The recommended dose of Biaxin for MAC treatment is 500 mgbid and the annual cost of treatment is $1,800 per year. Biaxinwas previously approved for adult upper respiratory infectionand skin infection. FDA is currently reviewing an applicationfor pediatric indications, including otitis media.

Abbott noted that MAC, one of the most common systemicbacterial infections in people with AIDS, has been estimated bythe Centers for Disease Control and Prevention to occur in oneof four AIDS patients.

Citing the results of a 12-week multicenter AIDS Clinical TrialsGroup (ACTG) study of 154 AIDS patients, Abbott said themajority of patients treated with Biaxin had decreases in MACbacteremia or negative cultures. "Reductions of the colonyforming units (CFUs) of MAC in the blood -- a measure of theextent of infection -- were seen within the first two weeks ofBiaxin therapy and at examination during the 12-week acutephase of the study," Abbott said.

"When compared to the number of MAC organisms initiallypresent in the blood, Biaxin 500 mg bid reduced the medianMAC count by 99.4 percent in 28 of 47 patients remaining inthe study at the 12-week point," the company said. "By 12weeks, 25 percent of patients treated with Biaxin 500 mg twicedaily continued to have negative cultures, while 23 percent haddied or discontinued the study and 14 percent had relapsed."

Abbott added that resistant organisms were observed at theeighth week of therapy, which the company said is expectedwith a single-agent therapy for MAC.

Abbott also noted that Biaxin improved patients' symptoms,decreasing fevers and night sweats and increasing weight. Themost frequently reported adverse effects with the drug werenausea, vomiting, taste perversion, abdominal pain, diarrhea,rash, headache and flatulence.

-- Brenda Sandburg News Editor

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