TGA approval for CSL Behring lung therapy

Company News

The TGA has approved CSL Behring's ZEMAIRA for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

AATD is a hereditary condition that can severely affect a patient’s lung function. The condition is marked by a low level or absence of Alpha-1 Proteinase Inhibitor (A1-PI), a natural protein that inhibits neutrophil elastase, thereby protecting the lungs from inflammation.

Severe deficiency of A1-PI is associated with a strong tendency for the development of emphysema and can significantly impact quality of life and life expectancy.

According to Steven Knowles, President of the Alpha-1 Association of Australia, “Alpha-1 patients in Australia have been waiting for almost 30 years now for access to Alpha-1 therapy. The success of CSL Behring in attaining registration of ZEMAIRA brings broad patient access to this therapy an important step closer to reality.”

“Alpha-1 patients around Australia now eagerly await the government’s assistance with subsidising access to this life extending therapy," he added.

ZEMAIRA is a highly purified A1-PI derived from human plasma. The company said it is the only A1-PI to be proven in a prospective double-blind, placebo controlled trial (RAPID study) to significantly reduce the loss of lung tissue, slowing the progression of emphysema due to AATD.

“AATD is a potentially debilitating disease and many affected individuals suffer from serious lung disease," said Respiratory Physician, Dr Jonathan Burdon AM.

“With the approval of ZEMAIRA in Australia, healthcare professionals can target treatment to reduce patients’ rate of decline in lung function, thereby improving productivity and quality of life and reducing morbidity. This is very good news for people with Alpha-1 Antitrypsin Deficiency,” said Dr Burdon.

Loretta Croker, General Manager, CSL Behring Australia/New Zealand, said, “ZEMAIRA delivers on CSL’s promise to develop and provide innovative specialty biotherapies to patients with unmet medical needs. We are committed to bringing ZEMAIRA to Australian patients and we hope that TGA approval raises awareness of Alpha-1 and helps progress patients’ diagnosis and treatment.”

The company said it anticipates a funding submission to the National Blood Authority in the next 6-12 months.