Optimer gets the NDA rolling for C. Diff therapy fidaxomicin
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Optimer Pharmaceuticals announced Sept. 22 that it has submitted the first section of a rolling NDA for its macrocyclic antibiotic fidaxomicin to treat patients with Clostridium difficile and to prevent recurrences. Relapse is a major concern with the opportunistic disease of hospitalized patients whose intestinal flora are thrown out of balance by broad-spectrum antibiotics aimed at other bacteria. Optimer plans to complete the submission in the fourth quarter and to request priority review, which could lead to regulatory action in the second quarter of 2011. Fidaxomicin's narrow spectrum profile may eradicate C. diff selectively with minimal disruption to the normal intestinal flora, unlike the current standard of care off-label metronidazole and vancomycin, according to Optimer. Relapse rates with standard of care are 20% to 30%. Although Optimer has the lead new agent in the field, other companies are working on an answer to C. diff ( 1"Fighting C. Difficile: Beyond Optimer's Fidaxomicin," Pharmaceutical Approvals Monthly, February 2010)
You may also be interested in...
Chart: Fighting C. Difficile: Beyond Optimer's Fidaxomicin
Optimer released positive data Feb. 4 from its second pivotal Phase III trial of fidaxomicin, raising hopes that hospitals will soon have a new weapon for fighting new deadly strains of Clostridium difficile, a bacterium that occurs naturally in the gut and is ordinarily benign. Problems arise, however, when antibiotics used to treat hospital-acquired infections eliminate other resident flora, allowing novel and toxic strains of C. diff to proliferate. Outbreaks of the disease, typified by diarrhea, nausea and in severe cases, colitis, sepsis and death, have made headlines in the United Kingdom and Canada.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.