Sepsivac receives Philippines FDA's approval for Covid treatment

© The Manila Times No Image

ON Sept. 15, 2021, Biocare Lifesciences Inc., the exclusive importer and distributor of Sepsivac (Mycobacterium w) in the Philippines received first Compassionate Special Permit after the approval of Food and Drugs Administration (FDA) approved the drug for Covid-19 treatment.

Sepsivac – A First-In-The-World Innovation for Sepsis Management was developed under the New Millennium India Technology Initiative (NMITLI) program of Council of Scientific and Industrial Research (CSIR) and is manufactured by Cadila Pharmaceuticals Ltd., Ahmedabad.

“Being able to now offer Sepsivac to Coronavirus patients and medical care partners is an exciting step forward for Biocare, and the partnership with Cadila Pharmaceuticals Ltd. Is one that we are extremely proud of,” said Dileep Tiwari, managing director, at Biocare Lifesciences Inc. “With the launch of Sepsivac, we’re currently ready to satisfy our objective and mission in acquiring quality and affordable medicine in this time of pandemic. Having Sepsivac is a great addition to the company’s product portfolio for Covid-19. This is after we launched Remdesivir and Favipiravir last year and Tocilizumab on April 2021.”

Sepsivac contains heat-killed Mycobacterium W (Mw), an immunomodulator. The immunomodulator effect was found to reduce the mortality rate of critically ill patients suffering from gram-negative sepsis by more than half.

“The efficacy of Sepsivac, originally used for the treatment leprosy was repurposed for use against Covid-19,” according to the Ronald Palacio, business unit head of Biocare Lifesciences Inc. He likewise added “Based on the clinical studies conducted for moderate to severe Covid-19 patient, Sepsivac effectively saves more lives in Sepsis. Randomized trials in Sepsis patients showed 11 percent absolute reduction and 55.5 percent relative reduction in mortality. Additionally, hospitalized Covid-19 patients reduces the days on ventilator, ICU stay, hospital stay, incidences of secondary infection and days on vasopressor and reduces the SOFA score.”

Sepsivac is available in 0.6ml/vial sterile suspension for injection and given intradermal at 0.3 mL per day (3 injections of 0.1ml) at three different sites for three consecutive days.

Like other nations, Philippines also permitted special importation of the drug on compassionate grounds as the country sees rise in Covid-related ailments.

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