Boehringer Ingelheim’s New Drug – Nintedanib – Lowers Pulmonary Fibrosis by 57%
By Judy Ya-Hsuan Lin
Boehringer Ingelheim, a research-driven pharmaceutical company, is devoted to improving the health of humans and animals by focusing on diseases for which no satisfactory treatment option pre-exists. An example of a recent actualization of their goal, Boehringer Ingelheim developed drug therapy for pulmonary fibrosis using nintedanib, or Ofev – approved in more than 70 countries. In September of 2019, the U.S. approved nintedanib, to date the first and only therapy to slow the rate of declining pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (ILD). “Progressive fibrosis of the lung can have a devastating impact on patients with a range of conditions. Yet, except for IPF and the newly approved therapy in the U.S., there are no medications approved for the treatment of progressive fibrosing ILDs.” This statement made by Professor Kevin Flaherty, M.D., Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan in Ann Arbor, reflects the current medical limitations met when treating progressive fibrosing ILDs in particular since there are over 80,000 people with ILDs already treated with nintedanib. Nintedanib is one of the few antifibrotic drugs helping slow the progression of pulmonary fibrosis. Boehringer Ingelheim’s clinical data, as well as prolific academics’ endorsements, substantiate the efficacy and low-risk for this new but prospective drug therapy for fibrotic pulmonary diseases.
A Successful Clinical Trial in Proving Nintedanib’s Efficacy and Low-RIsk
Recently, the New England Journal of Medicine and the European Respiratory Society (ERS) Congress published and presented significant findings and data regarding the Phase II INBUILD clinical trial for nintedanib on patients. Boehringer Ingelheim launched INBUILD, the first clinical trial in the field of ILDs to group patients based upon the clinical behavior of patients’ diseases, instead of primary clinical diagnosis. The INBUILD clinical trial is a “randomized, double-blind, placebo-controlled, parallel-group trial conducted at 153 sites in 15 countries that evaluate the efficacy, safety and tolerability of nintedanib [(150mg per 2 weeks)]” over the course of 52 weeks in patients with progressive fibrosing interstitial lung disease. In addition, all selected patients are over 18 years old with solely ILD, instead of IPF. Compared to the treatment with the placebo, Nintedanib slowed lung function decline by 57% across the overall study population. The statistics are obtained from the assessments of “the annual rate of decline in forced vital capacity (FVC) over 52 weeks of monitoring in patients with ILDs with signs of progression.” The placebo has an annual decline rate of over 52 weeks in FVC of -187 ml per year, while nintedanib has -80 ml per year; thus, there is a statistically significant difference of p< 0.001. “FVC is a lung function test measuring the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.” In other words, if the lungs cannot secure a sufficient amount of air for a forced exhalation, the lower the FVC value is. However, the reporting rate of the most common adverse effect, diarrhea, when using nintedanib is unfortunately triple that of the placebo, as 66.9% in nintedanib versus 23.9% in placebo.
Despite the lack of clarity for their placebo, the Phase III INBUILD still demonstrates ties between nintedanib and placebo in comparison to the annual decline rate of FVC and the reported rate of adverse effect. And yet, nintedanib is still given high evaluations by many academic elites and authorities. “We are very proud to be presenting the results of this first-ever clinical trial studying patients with different forms of progressive fibrosing ILDs, which are the basis of the regulatory applications that were recently submitted with the FDA and EMA [(European Medicines Agency)],” Dr. Mehdi Shahidi, M.D., Chief Medical Officer, Boehringer Ingelheim said. Susanne Stowasser, Boehringer’s associate head of respiratory medicine, spotlights that “we are now in a position that we will hopefully be soon able to offer these patients with these diseases [ILDs] a treatment because they currently do not have a treatment.” Stowasser bases this claim on the fact that the Phase llI INBUILD clinical trial presents positive signs that nintedanib could eventually be approved to treat a wide range of ILDs. However, Boehringer Ingelheim must still lower nintedanib’s side effect to not only create drug therapy that has not existed before but also give patients a drug-friendly therapy for a better quality of life.
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