Research Roundup: FDA advisory panel recommends approval of TB Alliance's TB treatment, innovation in women's health, and British syringe-free vaccine maker set to shake up the industry
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Independent experts of a US Food and Drug Administration (FDA) advisory panel voted in favor of TB Alliance’s treatment for multi-drug resistant and extensively drug-resistant tuberculosis (TB)— pretomanid—as part of a three-drug combination regimen with Johnson & Johnson’s bedaquiline and linezolid. Although the FDA is not bound to follow the advice of its advisory panel, it usually does. The FDA granted priority review for pretomanid and the marketing application is based on interim data from the first 45 patients in an ongoing study with a total of 109 participants. Current treatments for TB involve a cocktail of drugs and multiple injections, making adherence difficult for patients. Thus, “having a three-drug oral regimen will be a benefit,” said Philip LoBue, a panel member who voted in favor of the treatment. The FDA is expected to make a final decision on pretomanid’s approval by the third quarter of this year.
A new affordable option for combating post-partum hemorrhage—the number one killer of women during childbirth—was announced last week at the Women Deliver conference. The new device, Ellavi, is a high-quality uterine balloon tamponade (UBT) designed for low-resources settings that can be manufactured for US$10, as opposed to a typical cost of $200-250 for a UBT in most industrialized countries. Ellavi, developed by PATH and its South African partner Sinapi Biomedical, has achieved CE marking in Europe, signifying it meets regulatory requirements—an important mark of confidence that eases a product’s path to market in many countries. Ellavi is expected to be on the shelf initially in Kenya and Ghana by 2020, with plans for further expansion. PATH also announced the Nigerian National Agency for Food and Drug Administration’s marketing approval of Caya®—an updated, one-size-fits most, easier to grip, silicone-based diaphragm developed by PATH. Caya® will be introduced in Nigeria within the next year by DKT International, the largest family planning products and services provider in the country.
Oxford-based Enesi Pharma has developed a needle-free instrument, called ImplaVax, that can deliver vaccinations under the skin with practically no pain for the patient. Instead of being in liquid form, the vaccine is formed into a tiny, solid stick measuring 0.85mm in diameter and 3.5mm long, with a point at the end, which the ImplaVax device injects into the patient. In addition to being pain-free, this solid dose vaccination does not need to be kept cool—a particular benefit for countries with warmer climates and unreliable cold chains. With ImplaVax, there is also no risk of needle breakage and as a pre-measured solid dose, it is easy to administer, allowing the potential for lower-skilled health workers to administer rather than doctors or nurses. ImplaVax is still being tested in animals with the hope of beginning the first human studies next year.