We believe that MACRILEN will provide patients and physicians with a potentially safer, more tolerable and more convenient option for making accurate AGHD
diagnoses, and we look forward to working with the endocrinology community to bring MACRILEN to patients in the near future, Dr.
The study population consisted of 115 patients who were suspected of having AGHD as a result of the presence of one or more symptoms or risk factors.
This segment of the population included a range of patients from those considered at low risk of having AGHD to those considered at high risk.
Further, the company said it believes that if Macrilen is approved, it is likely to be rapidly adopted by physicians as the preferred means of evaluating AGHD
because it is safer than the ITT because it does not require the patient to become hypoglycemic; it is administered orally, while the ITT requires an intravenous infusion of insulin; the evaluation of AGHD
using Macrilen is significantly less time consuming and labor intensive than the ITT ; and the evaluation can be conducted in the physician's office rather than in a hospital setting.
Media reports about the federal law concerning HGH have created unnecessary confusion, and some reports have confused nonmedical over-the-counter homeopathic sprays and nutritional products with pharmaceutical-grade, FDA-approved injection medications for AGHD
Aeterna Zentaris is proud of our commitment to patients with suspected AGHD
and to the endocrinology community who we are confident will welcome an easier safe and effective oral diagnostic tool, said Michael V.
The EMA also agreed that the company may defer conducting the PIP until after it filed a MAA for the use of Macrilen in AGHD
At the time of removal, the trial consisted of 42 patients with AGHD
and ten control subjects.
David Dodd, Chairman, CEO at Aeterna Zentaris stated, The implementation of our own sales force and the field selling of ASCEND's EstroGel, mark an important step in our strategy of transitioning into a commercially operating specialty biopharmaceutical company, while the FDA continues its active NDA review for the approval of MacrilenTM in the evaluation of AGHD
With demonstrated synergies in pre-clinical studies, the combination of rhGH and rhIGF-1 could have the potential for several important therapeutic benefits compared to either rhGH or rhIGF-1 monotherapy alone for the treatment of patients with short stature and AGHD
and potentially other adult metabolic disorders.
We are actively pursuing our strategy to advance AEZS 130 towards regulatory approval for AGHD
, as it could become the first orally administered test in this indication.
Furthermore, we believe our request for Fast Track designation is warranted since there is currently no approved diagnostic test for AGHD
in North America, and AEZS-130 could provide a safe and effective test which would be more convenient because it is administered orally.