FDA approves Hib vaccine from GSK
PHILADELPHIA In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae Type b, GlaxoSmithKline has received accelerated approval from the Food and Drug Administration for Hiberix as a booster dose in children 15 months through 4 years of age.
Hib is an often severe and potentially deadly bacterial infection that can cause meningitis.
The Hib vaccine [Haemophilus b conjugate vaccine (tetanus toxoid conjugate)] shortage began in 2007 when another vaccine manufacturer temporarily suspended manufacturing of its Hib-containing vaccines. This led the Centers for Disease Control and Prevention to recommend temporary deferral of the booster dose for healthy children not at increased risk for Hib disease, GSK said.
Earlier this summer, the CDC reinstated the routine Hib booster dose due to an increase in supply. However, supply was not sufficient to support a mass catch-up effort for the millions of children who did not receive the booster dose during the shortage. Hiberix will help restore supply so children who missed the booster dose can get caught-up. Additionally, children coming in for routine visits can receive the Hib booster shot on time.
The CDC recommends that children receive the complete Hib vaccination series. The series includes a booster dose in the second year of life, in addition to a complete primary series of immunization in infants.
The review of Hiberix for the booster indication was conducted under accelerated approval regulations due to the shortage of Hib vaccine supply in the United States. GSK submitted safety and efficacy information from clinical studies conducted outside the United States for this review. In those studies, a booster dose of Hiberix following primary series vaccination provided protective levels of antibodies against Hib bacteria, regardless of the priming vaccine that was used.
“We are pleased that we were able to respond to this public health need,” said Peter Lammers, VP U.S. vaccines at GlaxoSmithKline. “GSK was able to act swiftly to increase supply of Hib vaccine so that children can complete the vaccination schedule as recommended by the CDC.”
More than 54 million doses of Hiberix have been distributed outside the United States since the 1996 launch in Germany, and the vaccine currently is registered in nearly 100 countries.
The vaccine is expected to be available within several weeks.
Exsulin Corp. releases clinical trial results for investigational diabetes drug
MINNEAPOLIS Results of a mid-stage clinical trial of a drug designed to restore the ability of the pancreas to produce insulin have appeared online in the journal Diabetes/Metabolism Research and Reviews, the drug’s manufacturer has announced.
Exsulin Corp. said it planned to move forward immediately on Exsulin (INGAP peptide), designed for use in patients with Type 1 and Type 2 diabetes.
“Since the landmark discovery of insulin in 1921, only incremental progress has been made in insulin therapy, which remains difficult and hazardous – particularly for people with [Type 1 diabetes],” Exsulin Corp. founder and chairman G. Alexander Fleming said in a statement. “These study results are very encouraging that Exsulin therapy could restore normal insulin secretion, which would allow insulin-dependent [Type 1 diabetes] and [Type 2 diabetes] patients to achieve normal glucose control while decreasing or ending their dependence on insulin treatment.”
Insulet Corp. appoints new chief commerical officer
BEDFORD, Mass. A company that develops insulin-pump technology without tubing, such as the OmniPod Insulin Management System, has created a new executive position.
Insulet Corp. announced this week the appointment of Peter Devlin as chief commercial officer, placing Devlin in charge of the company’s sales, marketing, business development, clinical research and customer care operations.
“Peter brings a distinguished track record in the diabetes and medical device industries, and we are extremely pleased to have him join Insulet’s management team,” Insulet president and CEO Duane DeSisto said in a statement.
Devlin previously worked as divisional VP global strategic marketing for diabetes care at Abbott Labs for 11 years.