Breaking News
January 23, 2019 - New certified reference material for testing residual solvents in cannabis
January 23, 2019 - Gene-edited chickens could prevent future flu pandemic
January 23, 2019 - Cardiovascular disease risk begins even before birth
January 23, 2019 - Younger patients receiving kidney transplant more likely to live longer, shows data
January 23, 2019 - Skin samples hold early signs of prion disease, research suggests
January 23, 2019 - Researchers discover how body initiates repair mechanisms that limits damage to myelin sheath
January 23, 2019 - Fecal transplant from certain donors better than others
January 23, 2019 - Risk for Uninsurance in AMI Patients Reduced With Medicaid Expansion
January 23, 2019 - Readmissions reduction program may be associated with increase in patient-level mortality
January 23, 2019 - Fostering translation and communication in medicine and beyond
January 23, 2019 - To Fight Fatty Liver, Avoid Sugary Foods and Drinks
January 23, 2019 - TPU scientists develop new implants that double the rate of bone lengthening in kids
January 23, 2019 - New sessions at Pittcon 2019
January 23, 2019 - Insilico to present latest findings in AI for Drug Discovery at 3rd Annual SABPA FTD Forum
January 23, 2019 - Opioid overdose patients can be safely discharged an hour after administration of naloxone
January 23, 2019 - Scientists find bacterial extracellular vesicles in human blood
January 23, 2019 - Researchers gain new insights into development of necrotizing enterocolitis in preemies
January 23, 2019 - Medical expert advises people with epilepsy not to stockpile medicines
January 23, 2019 - Study outlines research priorities for improving pediatric patient care and safety
January 23, 2019 - Bedfont to exhibit NObreath FeNO monitor at Arab Health 2019
January 23, 2019 - Nicotinamide riboside supplementation confers significant physiological benefits to mothers and offspring
January 23, 2019 - Increasing temperatures may help preserve crop nutrition
January 23, 2019 - Many Oncologists in the Dark About LGBTQ Health Needs
January 23, 2019 - Epigenetic change causes fruit fly babies to inherit diet-induced heart disease
January 23, 2019 - Erasing memories could reduce relapse rates among drug addicts
January 23, 2019 - African Americans who smoke cigarettes are more likely to develop peripheral artery disease
January 23, 2019 - Unique data combination helps FinnGen researchers to fund links between genetic factors and health
January 23, 2019 - Parents’ mental health problems associated with reactive attachment disorder in children
January 23, 2019 - Graphene Flagship project studies impact of graphene and related materials on our health
January 23, 2019 - The connection between the Pope and contraceptive pills
January 23, 2019 - Prior dengue infection could protect children from symptomatic Zika
January 23, 2019 - Previous dengue virus infection associated with protection from symptomatic Zika
January 23, 2019 - VISTA checkpoint implicated in pancreatic cancer immunotherapy resistance
January 23, 2019 - The Tiny Camera That Could Revolutionize Cardiovascular Surgery
January 23, 2019 - Peptide isolated from soil fungi has antitumor and antibacterial properties
January 23, 2019 - TGen identifies polio-like virus as potential cause of Acute Flaccid Myelitis outbreak
January 23, 2019 - Migrants and refugees do not bring disease and are at greater health risk themselves says WHO
January 23, 2019 - Examing the effects of menopause in workplace
January 23, 2019 - Enemy number 1 – Air pollution and climate change top of WHO agenda
January 23, 2019 - Two Positive Phase III studies of Tafenoquine for the Radical Cure of Plasmodium vivax Malaria Published in The New England Journal of Medicine
January 23, 2019 - World Trade Center responders at increased risk for head and neck cancers
January 23, 2019 - Low-sugar diet leads to significant improvement in nonalcoholic fatty liver disease in boys
January 23, 2019 - Chaos in bodily regulation can optimize our immune system, finds study
January 23, 2019 - Short, text-based exercises can increase happiness for adults recovering from substance use disorders
January 23, 2019 - Body size may have greater influence on women’s lifespan than men
January 23, 2019 - Groundbreaking tool helps visualize neuronal activity with near-infrared light
January 23, 2019 - Prior dengue immunity in children may be protective against symptomatic Zika
January 23, 2019 - Holocaust survivors with PTSD and their offspring exhibit more unhealthy behavior patterns
January 23, 2019 - Scientists discover new genetic mutations causing inherited deaf-blindness
January 23, 2019 - UC team designs new naloxone-dispensing smart device
January 23, 2019 - Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP
January 23, 2019 - Brain activity shows development of visual sensitivity in autism
January 23, 2019 - Two hour gap between dinner and sleep is overrated says Japanese research
January 23, 2019 - Fear and embarrassment are causing smear test numbers to plummet
January 23, 2019 - Protein-secreting device implanted in epileptic rats reduces seizures, improves cognition
January 23, 2019 - Reintroduction project recovers current wild population of green turtle in Cayman Islands
January 23, 2019 - Cancer survivors face greater financial burden related to medical bills
January 23, 2019 - PSA screening reduces prostate cancer deaths by 30%
January 23, 2019 - LSTM receives grant to help improve health of people living in informal settlements
January 23, 2019 - Hemochromatosis Mutation Linked to Other Morbidity
January 23, 2019 - Why early diagnosis of autism should lead to early intervention
January 23, 2019 - Aspirin May Lower Stroke Risk in Women with History of Preeclampsia
January 23, 2019 - Exposure to certain chemicals may be linked to decrease in blood pressure during pregnancy
January 23, 2019 - Bowel cancer on the rise among younger Australians
January 23, 2019 - Scientists have reversed memory loss in a mouse model of Alzheimer’s
January 23, 2019 - Defective molecular master switch could lead to age-related macular degeneration
January 23, 2019 - Researchers identify how concussions may contribute to seizures
January 23, 2019 - Short interval between last meal of the day and bedtime may not affect blood glucose levels
January 23, 2019 - Still Too Many Highway Deaths Tied to Speeding
January 23, 2019 - Prenatal valproate exposure linked to increased ADHD risk
January 23, 2019 - Compound identified that may help treat heart failure
January 23, 2019 - Undiagnosed Asthma in Urban Adolescents May Be Common
January 23, 2019 - Study describes metabolism of intestinal microbiota in babies for the first time
January 22, 2019 - Study links concussions to development of epilepsy
January 22, 2019 - Specialist-led hospital bereavement service may help restrain legal action after difficult deaths
January 22, 2019 - Genetic study reveals possible new routes to treating osteoarthritis
January 22, 2019 - Blood test may detect early signs of lung-transplant rejection
January 22, 2019 - Blood marker could aid in early prediction of Alzheimer’s progression
January 22, 2019 - Orthodontic treatment does not guarantee future dental health
January 22, 2019 - Rutgers researchers discover cause of bone loss in people with joint replacements
Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency

Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency

image_pdfDownload PDFimage_print

Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency

CHARLESTON, S.C. December 20, 2017 — Aeterna Zentaris Inc. (NASDAQ and TSX: AEZS), a specialty biopharmaceutical company engaged in developing and commercializing pharmaceutical therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Macrilen (macimorelin), an orally available ghrelin agonist, to be used in the diagnosis of patients with adult growth hormone deficiency (AGHD). The Company estimates that approximately 60,000 tests for suspected AGHD are being conducted each year across the United States, Canada and Europe.

“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. Ward, Chief Executive Officer, Aeterna Zentaris. “In the absence of an FDA-approved diagnostic test for AGHD, Macrilen fills an important gap and addresses a medical need for a convenient test that will better serve patients and health providers.”

Macrilen (macimorelin) stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. Stimulated growth hormone levels are measured in four blood samples over ninety minutes after oral administration of Macrilen (macimorelin) for the assessment of growth hormone deficiency (“GHD”). Prior to the approval of Macrilen (macimorelin), the historical gold standard for evaluation of AGHD was the insulin tolerance test (“ITT”), an intravenous test requiring many blood draws over several hours. The ITT procedure is inconvenient for patients and medical practitioners and may contraindicate in patients, such as those with coronary heart disease or seizure disorder, because it requires the patient to experience hypoglycemia to obtain an accurate result.

“Clinical studies have demonstrated that growth hormone stimulation testing for AGHD with oral Macrilen (macimorelin) is reliable, well-tolerated, reproducible, safe and a much simpler test to conduct than currently available options,” said Kevin Yuen, MD, clinical investigator and neuroendocrinologist, Barrow Neurological Institute, and medical director of the Barrow Neuroendocrinology Clinic, Phoenix, Arizona. “The availability of Macrilen (macimorelin) will greatly relieve the burden of endocrinologists in reliably and accurately diagnosing AGHD.”

Aeterna Zentaris intends to make Macrilen (macimorelin) available commercially in the United States during the first quarter of 2018.

About Aeterna Zentaris Inc.

Aeterna Zentaris Inc. is a specialty biopharmaceutical company focused on developing and commercializing Macrilen™ (macimorelin). On November 27, 2017 Aeterna Zentaris announced that the Marketing Authorization Application (MAA) for the use of Macrilen™ (macimorelin) for the evaluation of AGHD was accepted by the European Medicines Agency (EMA) for regulatory review. For more information, visit www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe-harbor provisions of the U.S. Securities Litigation Reform Act of 1995 and applicable Canadian securities laws, which reflect our current expectations regarding future events. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “would,” “could,” “may,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known risks and uncertainties, many of which are discussed under the caption “Key Information – Risk Factors” in our most recent Annual Report on Form 20-F filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission (“SEC”). Such statements include, but are not limited to, statements about the timing of, and prospects for, regulatory approval and commercialization of our product candidates, statements about the status of our efforts to establish a commercial operation and to obtain the right to promote or sell products that we did not develop and estimates regarding our capital requirements and our needs for, and our ability to obtain, additional financing. Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our now heavy dependence on the success of Macrilen™ (macimorelin) and the continued availability of funds and resources to successfully launch the product, and, more generally, uncertainties related to the regulatory process, the rejection of the MMA by the EMA and the ability of the Company to efficiently commercialize Macrilen™ (macimorelin), the degree of market acceptance of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our products, the impact of securities class action litigation, the litigation involving two former officers of the Company, or other litigation, on our cash flow, results of operations and financial position; any evaluation of potential strategic alternatives to maximize potential future growth and stakeholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company’s quarterly and annual filings with the applicable Canadian securities regulators and the SEC for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.

Source: Aeterna Zentaris Inc.

Posted: December 2017

Related Articles:

  • NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults Granted December 30, 2017 PDUFA Date – July 18, 2017
  • Aeterna Zentaris Resubmits NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults – June 30, 2017
  • Aeterna Zentaris Intends to File NDA with Respect to Macrilen in Third Quarter of 2017 – March 30, 2017
  • Aeterna Zentaris Announces Plans to Pursue FDA Registration of Macrilen – February 13, 2017
  • Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen – October 26, 2016
  • Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD – April 13, 2015
  • FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency – November 6, 2014
  • Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA – January 6, 2014
  • Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD – November 5, 2013

Macrilen (macimorelin) FDA Approval History

Tagged with:

About author

Related Articles