AGHD

AcronymDefinition
AGHDAdult Growth Hormone Deficiency
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The study population will consist of approximately 110 subjects (at least 55 ITT-positive and 55 ITT-negative) with a medical history documenting risk factors for AGHD, and will include a spectrum of subjects from those with a low risk of having AGHD to those with a high risk of having the condition.
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.
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 patients.
The study population will consist of patients with a medical history documenting risk factors for AGHD and will include a spectrum of patients from those with a low risk of having AGHD to those with a high risk of having the condition.
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.
Macrilen(TM) has been granted orphan drug designation by the FDA for use in AGHD.
The NDA for Macrilen[TM] continues to be under review, with a PDUFA date of November 5 of this year, and we have been in continued discussions with the FDA; if approved, Macrilen[TM] would become the first FDA approved oral drug for use in evaluating AGHD.
David Dodd, Aeterna Zentaris President and CEO, commented, "Over the last twelve months, we made great strides in the transition toward becoming an operating biopharmaceutical company, filing the NDA for MACRILEN[TM] for the evaluation of AGHD and initiating patient recruitment for the pivotal ZoptEC Phase 3 trial in endometrial cancer with zoptarelin doxorubicin.
The Company's NDA, submitted on November 5, 2013, seeks approval for the commercialization of macimorelin acetate as the first orally-administered product that induces growth hormone release to evaluate AGHD.
To that effect, we have submitted a NDA for macimorelin acetate as potentially the first approved oral product for the evaluation of AGHD, we have appointed a Chief Commercial Officer responsible for all macimorelin acetate branding, marketing and sales activities, as well as for overseeing future commercial opportunities.
David Dodd, President and CEO of Aeterna Zentaris, commented, "The submission of the NDA to the FDA is another major milestone in our strategy to bring macimorelin acetate to market as the first approved oral product for AGHD evaluation.
Phase 3 data have demonstrated that the compound has the potential to become the first orally-approved diagnostic test for AGHD, with accuracy comparable to available testing procedures.