Daxas (roflumilast)
March 12, 2004 by admin · Leave a Comment
On March 12, 2004 Altana AG announced that it had presented strong data on its Chronic Obstructive Pulmonary Disease (COPD) drug roflumilast, also known as Daxas, at a German scientific meeting. Daxas, which is to be jointly marketed with Pfizer, has been filed for marketing approvals in Europe. Altana has said it hopes Pfizer will file for U.S. approvals by next February.
An Altana executive said the Phase III study, involving nearly 1,800 patients over six months, had shown that patients on a 500-microgram dosage of the drug showed 0.75 exacerbations over the study period compared to 1.13 exacerbations in a placebo group. Exacerbations are defined as an acute worsening of the patient’s condition, leading to treatment with oral steroids or a combination of steroids and antibiotics. In most cases, hospitalization is required.
Daxas is a member of a class of drugs known as phosphodiesterase inhibitors. Phosphodiesterases (PDEs) belong to an important family of proteins that regulate the intracellular levels of cyclic nucleotide second messengers. Targeting PDE with selective inhibitors may offer novel therapeutic strategies in the treatment of various conditions. In the context of respiratory disease, these include asthma and chronic obstructive pulmonary disease (COPD).
COPD refers to a group of diseases that cause airflow blockage and breathing-related problems. It includes emphysema, chronic bronchitis, and in some cases asthma. COPD is a leading cause of death, illness, and disability in the United States. In 2000, 119,000 deaths, 726,000 hospitalizations, and 1.5 million hospital emergency departments visits were caused by COPD. An additional 8 million cases of hospital outpatient treatment or treatment by personal physicians were linked to COPD in 2000.
If approved, Daxas would represent the first PDE inhibitor indicated for the prevention of COPD exacerbations. At this time, the date of Pfizer’s FDA submission is not known. Although we see Daxas as a High Impact Technology, we recommend no assessment activities until Pfizer’s plans for Daxas in North America become clear.
Technology Details
Target Disease / Indication
COPD
Technology Classification
Drug
Body System
Respiratory System
Program Area
Medicine/Respirology
Regulatory Status
Phase III
BioHorizon Impact Score
78/100 – High
