Cytodyn Inc (CYDY)

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Seeking Alpha

FDA OKs TaiMed's HIV med ibalizumab http://www.seekingalpha.com/news/3336851

• The FDA approves privately held TaiMed Biologics' Trogarzo (ibalizumab-ulyk) for the treatment of adults with chronic HIV infection who have not responded adequately to other treatments.
• Ibalizumab, a humanized monoclonal antibody, is administered intravenously once every 14 days and is used with other antiretroviral medications.
• In a clinical trial involving 40 heavily pretreated patients with multidrug-resistant HIV-1 infection who continued to have high levels of virus in their blood despite antiretroviral therapy (most had received 10 or more antiretroviral drugs), 43% achieved HIV RNA suppression after 24 weeks of Trogarzo.
• On the safety front, the most common adverse events were diarrhea, dizziness, nausea and rash. Severe adverse events included rash and immune reconstitution syndrome, a condition in some HIV patients where the immune system recovers but then responds to a previously acquired opportunistic infection with an overwhelming immune (inflammatory) response.