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news.Biopharmaceutical company Sequella has reported that the FDA and the European Medicines Agency have independently reviewed its lead drug compound for the treatment of tuberculosis, and both the agencies have granted orphan drug status for it.
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Sequella’s lead drug, SQ109, shows excellent in vitro and in vivo activity against drug-susceptible and drug-resistant tuberculosis (TB) bacteria, including XDR-TB, according to the company. Furthermore, SQ109 synergizes with other TB drugs in experimental animal models of TB, and could result in new TB drug combinations that have much greater activity than the current standard of care.
Dr Carol Nacy, founder, CEO and chair of the board, said: “We are pleased that the FDA and the European Medicines Agency awarded Sequella orphan drug and orphan medicinal product status for the use of SQ109 for the treatment of TB, a chronically debilitating and life-threatening infectious pulmonary and extrapulmonary disease.”