FDA advisory committee recommends expanded use of Pfizer vaccine
NEW YORK A Food and Drug Administration advisory committee has voted in favor of approving an expanded version of a pneumococcal disease vaccine for children and infants made by Pfizer, Pfizer announced.
The drug maker said Wednesday that the FDA’s Vaccines and Related Biological Products Advisory Committee voted 10-to-1 in favor of the safety and efficacy of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]), which ads six serotypes to the existing seven-serotype version of Prevnar.
An FDA advisory committee vote does not guarantee approval for a drug or vaccine, but the FDA will take the committee’s recommendation into account when making a final decision.
Prevnar 13 is designed to protect against the serotypes 4, 6B, 9V, 14, 18C, 19F and 23F that Prevnar protects against, plus 1, 3, 5, 6A, 7F and 19A. According to a 2002 estimate by the World Health Organization, pneumococcal disease, caused by the bacteria S. pneumoniae, is a leading cause of vaccine-preventable death in children younger than 5 years.
FDA approves Qutenza
ROCKVILLE, Md. A substance familiar to diners at Mexican and Sichuan Chinese restaurants also is the active ingredient in a newly approved drug for treating pain resulting from shingles.
The Food and Drug Administration announced Tuesday the approval of Qutenza, a patch made by Andernach, Germany-based Lohmann Therapy Systems. The patch uses capsaicin, the compound that gives chili peppers their bite, to treat pain from postherpetic neuralgia. PHN occurs in more than 10% of patients who have had shingles, an outbreak of rash and blisters on the skin caused by the varicella-zoster virus, the same virus that causes chickenpox.
The FDA said Qutenza was the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo review by the agency, having gained approval Monday.
“This new product can provide effective pain relief for patients who suffer from PHN,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said in a statement.
Pfizer seeks to develop tropical disease treatments
GENEVA The world’s largest drug maker plans to tackle rare tropical diseases.
Pfizer announced Wednesday a partnership with Drugs for Neglected Diseases Initiative under which the two will develop drugs to treat human African trypanosomiasis, visceral leishmaniasis and Chagas disease.
Those names may sound unfamiliar to people in North America, but they have devastating effects on people in developing countries. Chagas disease, for example, results from infection by a protozoan parasite spread by the kissing bug, a relative of the assassin bugs and stink bugs common in American gardens that feeds on people’s blood while they sleep. The parasite infects the heart and can cause death unless the patient receives multiple heart transplants over the course of his or her life.
“Despite considerable progress made in recent years, these three diseases continue to take a terrible human toll and represent a significant social burden for developing countries,” Pfizer Global Research & Development chief scientific officer for antivirals and VP Manos Perros said in a statement. “We are expanding our commitment to the fight against tropical diseases by joining forces with DNDi by sharing our collection of chemical compounds and the knowledge and expertise associated with these chemical entities.”
DNDi will have access to a library of 150,000 compounds that it will test against the three diseases, seeking compounds that work against the parasites. DNDi scientists will conduct the tests for human African trypanosomiasis at the Eskitis Institute for Cell and Molecular Therapies at Griffith University in Brisbane, Australia, while tests for the other two diseases will take place at the Institut Pasteur Korea.