FDA accepts Teva approval application for BDP Nasal HFA
JERUSALEM — The Food and Drug Administration has accepted an approval application for a drug made by Teva Pharmaceutical Industries for treating allergies, Teva said.
The Israeli drug maker said the FDA accepted its application for BDP Nasal HFA (beclomethasone dipropionate hydrofluoroalkane) for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis. The drug is a nasal aerosol corticosteroid.
"BDP Nasal HFA has demonstrated promising results in the treatment of both SAR and PAR, and we remain committed to addressing unmet needs and dissatisfaction with currently available treatments among the 60 million patients in the [United States] who suffer from allergic rhinitis," Teva group VP global branded products Yitzhak Peterburg.
Roche drug improves lung function in patients with uncontrolled asthma, study finds
BASEL, Switzerland — An investigational treatment made by Roche for asthma increased lung function in patients who could not adequately control their disease with inhaled corticosteroids, according to results of a mid-stage clinical trial.
Results of the phase-2 "MILLY" study of lebrikizumab were published last week in the New England Journal of Medicine. The drug is a humanized monoclonal antibody designed to block interleukin-13 cytokine, a key contributor to asthma that also increases levels of the protein periostin, which can be measured with a blood test.
"The findings of the MILLY study and the development of a potential biomarker have shown that we may be able to select appropriate asthma patients for lebrikizumab therapy," said Richard Scheller, EVP Genentech Research and Early Development, a division of Roche. "These results support further investigation of lebrikizumab as a personalized medicine for patients who suffer from moderate to severe uncontrolled asthma."
Single-ingredient acetaminophen for kids hits store shelves
WASHINGTON — Uniform concentrations of single-ingredient liquid pediatric acetaminophen medicines have been making their way to the shelf as promised by the Consumer Healthcare Products Association earlier this year, as evidenced by these new product facings from PediaCare and Triaminic. Note, too, that both new formulations feature uniform age-appropriate dosing devices, in this case syringes.
It’s just another example of how the consumer healthcare association proactively addresses concerns in the industry.