register

News & Trends - Pharmaceuticals

First treatment approved for progressive interstitial lung diseases – Boehringer Ingelheim

Health Industry Hub | March 10, 2020 |

Pharma News: Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approval of Ofev (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype – encompassing more than 200 disorders and classified as rare diseases.

“The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, M.D., acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now.”

Ofev, a multi-targeted tyrosine kinase inhibitor that inhibits key pathways involved in lung fibrosis in ILDs, is currently approved for idiopathic pulmonary fibrosis (IPF) and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD (SSc-ILD), two types of ILDs. This new approval now makes Ofev available for patients with chronic fibrosing ILDs in which lung fibrosis continues to worsen.

Enhance corporate branding and boost thought leadership to attract and retain quality employees. How does your company culture and digital footprint measure up in the Australian Pharma industry? Get the benchmark report by contacting us.

The FDA approval is based on the INBUILD trial, the first Phase III clinical trial in the field of ILDs to group patients based on the clinical behaviour of their disease rather than the primary clinical diagnosis.

“Chronic fibrosing ILDs with a progressive phenotype lead to respiratory symptoms and worsening lung function,” said Kevin Flaherty, M.D., professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan in Ann Arbor, Michigan, and lead investigator of the INBUILD trial. “This approval provides a therapeutic option for many patients who did not have an approved treatment until today.”

Interstitial lung diseases encompass more than 200 disorders, which are classified as rare diseases, that can lead to pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function. Chronic fibrosing ILDs in which lung fibrosis continues to worsen are estimated to occur in 18 to 32 percent of patients with ILDs.

“As a leader in the field of ILD research, we are fully committed to better understanding how to treat these devastating diseases,” said Thomas Seck, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Today’s approval marks a major advancement in ILD research and is an important milestone just six months after the approval of Ofev to slow the rate of decline in pulmonary function in patients with SSc-ILD.”

“Patients with a progressive form of chronic fibrosing ILDs may have symptoms that are similar to other respiratory illnesses and that may delay getting an accurate diagnosis for patients,” said Greg Cosgrove, M.D., chief medical officer, Pulmonary Fibrosis Foundation. “The new indication for nintedanib provides a therapeutic option for physicians and their patients as there is now a treatment option that can help slow the decline in lung function.”

Register FREE to receive the latest industry news, innovations and insights from Health Industry Hub; the only one-stop-hub connecting Australia’s Pharma, MedTech and Biotech industry professionals and its key stakeholders.


News & Trends - Pharmaceuticals

Lilly's drug cuts diabetes risk by 94%, so why is it still not on the PBS?

Lilly’s drug cuts diabetes risk by 94%, so why is it still not on the PBS?

Health Industry Hub | November 14, 2024 |

On World Diabetes Day (14 November), new data reveals that three years of treatment with a GIP/GLP-1 receptor agonist significantly […]

More


News & Trends - Biotechnology

Depaz Oration to celebrate an 'enduring' legacy in the biotech sector

Depaz Oration to celebrate an ‘enduring’ legacy in the biotech sector

Health Industry Hub | November 14, 2024 |

AusBiotech announced the establishment of the Depaz Oration, an annual keynote event that will debut at the AusBiotech Conference in […]

More


News & Trends - Pharmaceuticals

Government calls for public input on genomic-led cancer care

Government calls for public input on genomic-led cancer care

Health Industry Hub | November 14, 2024 |

The Australian Government has launched a public consultation on a draft policy framework aimed at enhancing genomics-informed cancer care nationwide. […]

More


News & Trends - MedTech & Diagnostics

Can the patient voice reduce low-value care? Australia’s first large-scale hospital initiative seeks answers

Can the patient voice reduce low-value care? Australia’s first large-scale hospital initiative seeks answers

Health Industry Hub | November 14, 2024 |

In an Australian-first, a not-for-profit private health insurer will ask hospital patients to rate not only their clinical care but […]

More


This content is copyright protected. Please subscribe to gain access.