Drugs

FDA Approves Pretomanid for Treating Some TB

FDA has approved the Global Alliance for TB Drug Development’s Pretomanid tablets to be used in combination with bedaquiline and linezolid to treat a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant, or non-responsive multidrug resistant pulmonary tuberculosis. An agency statement says that multidrug-resistant TB and extensively drug-resistant TB are difficult to treat due to resistance to available therapies.

Pretomanid’s safety and effectiveness, taken orally in combination with bedaquiline and linezolid, was primarily demonstrated in a study of 109 patients with extensively drug-resistant, treatment intolerant, or non-responsive multidrug-resistant pulmonary tuberculosis. Of the 107 patients evaluated six months after the end of therapy, 89% were successes, which significantly exceeded the historical success rates for treatment of extensively drug resistant TB, the agency says.

The most common adverse reactions associated in patients treated with the three drugs in combination were peripheral neuropathy, acne, anemia, nausea, vomiting, headache, increased live enzymes, indigestion, rash, increased pancreatic enzymes, visual impairment, hypoglycemia, and diarrhea.

Pretomanid is the second drug approved by FDA under the limited population pathway for antibacterial and antifungal drugs established by the 21^st Century Cures Act to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need. The drug also received FDA’s qualified infectious disease product designation that is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now title of the FDA Safety and Innovation Act. And it was granted priority review and an orphan drug designation.

The Global Alliance for TB Drug Development was awarded a tropical disease priority review voucher under a provision in the FDA Amendments Act of 2007 intended to encourage development of new drugs and biological products for preventing and treating certain tropical diseases.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome