Parathyroid hormone

Entera Bio Announces Publication of Oral PTH(1-34) Peptide Tablets (EB613) Phase 2 Trial Data in the Journal of Bone and Mineral Research

Retrieved on: 
Monday, April 8, 2024
Tablet, Woman, Osteoporosis, Hip, Parathyroid hormone, Patient, Journal, BMD, Treatment, Injection, Spine, PTH, Dietary supplement

Miranda Toledano, CEO of Entera, commented, “We are excited to share that data from our successful Phase 2 study of EB613 has been accepted and now published in the prestigious JBMR.

Key Points: 
  • Miranda Toledano, CEO of Entera, commented, “We are excited to share that data from our successful Phase 2 study of EB613 has been accepted and now published in the prestigious JBMR.
  • We believe EB613 addresses the current treatment gap in osteoporosis as the first oral, osteoanabolic (bone building) once-daily tablet treatment due to its unique format and potential dual mode of action.
  • The highest EB613 oral PTH tablet dose (2.5 mg), produced an increase in markers of bone formation while simultaneously decreasing the markers of bone breakdown.
  • The 2.5 mg oral PTH tablet dose was well tolerated when patients were instructed to titrate up to the full dose.

Ascendis Pharma Launches 2nd TransCon™ Product: YORVIPATH® Now Available in Germany and Austria for Adults with Chronic Hypoparathyroidism

Retrieved on: 
Wednesday, January 31, 2024
Vision 2030, PTH, Patient, Physician, Parathyroid hormone, Hypoparathyroidism, Pharmaceutical industry

COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria.

Key Points: 
  • COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria.
  • YORVIPATH is the second product developed with Ascendis Pharma’s TransCon technology platform to be launched commercially.
  • “We are pleased to initiate the launch of YORVIPATH to address the needs expressed within the hypoparathyroidism community for a new PTH-based treatment option,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.
  • With an increasingly broad commercial infrastructure in place, we are well positioned to accomplish this by expanding the availability of YORVIPATH and our other approved products to meet the needs of physicians and patients around the world.”

Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Urine, Medical Subject Headings, Marketing, INN, Risk, Fracture, Alkaline phosphatase, Woman, Allergy, Heart rate, Vitamin D, ATC, Hypercalcaemia, Menopause, International, Diet, Parathyroid hormone, Headache, Disease, Osteosarcoma, Nausea, Blood, Language, Calcium, Osteoblast, Palpitations, Cancer, Heart, Dizziness, Abdomen, European Medicines Agency, Spine, Back pain, Hypercalciuria, Select, System, Safety, Cardiovascular disease, Anatomy, Arthralgia, Bone fracture, Female, IIA, Skin, Medical device

Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Yorvipath, Palopegteriparatide, Date of authorisation: 17/11/2023, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Gland, Medical Subject Headings, Marketing, INN, ATC, EMA, International, Parathyroid hormone, Headache, Needle, Disease, Language, Blood, Calcium, Teriparatide, PTH, Heart, Pseudohypoparathyroidism, European Medicines Agency, EMEA, Select, Patient, Diagnosis, Anatomy, Paresthesia, IIA, Neck, Skin, Medical device

Hypoparathyroidism is rare, and Yorvipath was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 October 2020.

Key Points: 
  • Hypoparathyroidism is rare, and Yorvipath was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 October 2020.
  • Teriparatide replaces the missing hormone in patients with hypoparathyroidism, acting through bone tissue and the kidneys to help restore calcium levels.
  • The European Medicines Agency therefore decided that Yorvipath’s benefits are greater than its risks and it can be authorised for use in the EU.
  • Yorvipath : EPAR - Medicine overview
    Product information
    Yorvipath : EPAR - Product information
    Latest procedure affecting product information: EMEA/H/C/005934
    This medicine’s product information is available in all official EU languages.

FDA Accepts for Review Resubmitted NDA for TransCon PTH (Palopegteriparatide) in Adult Patients with Hypoparathyroidism

Retrieved on: 
Monday, December 11, 2023
Hypoparathyroidism, FDA, PDUFA, Parathyroid hormone, NDA, PTH, Patient, Pharmaceutical industry

COPENHAGEN, Denmark, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism. The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024. In the United States, TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.

Key Points: 
  • – PDUFA goal date is May 14, 2024
    COPENHAGEN, Denmark, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism.
  • In the United States, TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.
  • “We are pleased that the FDA can continue its review of TransCon PTH and look forward to working with the agency during its review,” said Jan Mikkelsen, President and CEO at Ascendis Pharma.
  • “Given the significant unmet needs of the hypoparathyroidism community, we remain committed to making TransCon PTH available for U.S. patients as rapidly as possible.”

Ascendis Pharma Announces European Commission Approval of YORVIPATH® (palopegteriparatide) for the Treatment of Adults with Chronic Hypoparathyroidism

Retrieved on: 
Monday, November 20, 2023
Hypoparathyroidism, European Commission, Science, Physician, EMA, Parathyroid hormone, Health, Disease, Civil service commission, PTH, TU Dresden, European Medicines Agency, Committee, Patient, Diagnosis, Institute of technology, CHMP

COPENHAGEN, Denmark, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for YORVIPATH® (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. YORVIPATH is a prodrug of parathyroid hormone (PTH 1-34) administered once daily. Ascendis plans its first European Union (EU) launch of YORVIPATH in January 2024 in Germany.

Key Points: 
  • COPENHAGEN, Denmark, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for YORVIPATH® (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.
  • Ascendis plans its first European Union (EU) launch of YORVIPATH in January 2024 in Germany.
  • Treatment should be initiated and monitored by physicians or qualified healthcare professionals experienced in the diagnosis and management of patients with hypoparathyroidism.
  • TransCon PTH is in development for adults with hypoparathyroidism in the United States, Japan, and other countries.

Ascendis Pharma Resubmits NDA for TransCon™ PTH to the U.S. FDA

Retrieved on: 
Wednesday, November 15, 2023
NDA, Type, PTH, Patient, FDA, United, Southern Transcon, Health, New Drug Application, Hypoparathyroidism, Parathyroid hormone, Pharma, Pharmaceutical industry

COPENHAGEN, Denmark, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has resubmitted its New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adults with hypoparathyroidism to the U.S. Food & Drug Administration (FDA).

Key Points: 
  • COPENHAGEN, Denmark, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has resubmitted its New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adults with hypoparathyroidism to the U.S. Food & Drug Administration (FDA).
  • The resubmission follows the Type A meeting held with the FDA in late August.
  • “With results from two randomized, double-blind, placebo-controlled clinical trials of TransCon PTH and no new safety concerns identified in follow-up reaching up to four years, we believe TransCon PTH is well-positioned to meet the needs of the hypoparathyroidism community.
  • As no concerns were expressed by the FDA about the clinical data submitted as part of our original NDA, we look forward to working with the agency during its review of our updated manufacturing control strategy for TransCon PTH in the United States.”

New Clinical Data on OPKO Health’s RAYALDEE® (ER Calcifediol) Presented at Kidney Week 2023

Retrieved on: 
Thursday, November 2, 2023
EGFR, Secondary hyperparathyroidism, SHPT, ERC, Health, Glomerular filtration rate, HIV disease progression rates, Society, American Society of Nephrology, Phosphorus, Chronic kidney disease, Dialysis, Parathyroid hormone, ASN, Serum, OPKO Health, CKD, Patient, Calcium, Pharmaceutical industry

MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) presented late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia today.

Key Points: 
  • MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) presented late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia today.
  • Treatment with RAYALDEE was not associated with clinically meaningful increases in serum calcium or phosphorus.
  • “RAYALDEE is a safe and highly effective treatment for SHPT in patients with stage 3 or 4 CKD.
  • The new data presented today clearly highlight the possibility that raising serum 25-hydroxyvitamin D to a sufficiently high level to achieve consistent iPTH control with RAYALDEE would improve outcomes in CKD patients.”

Ascendis Pharma Presents TransCon™ PTH (palopegteriparatide) Phase 3 52-Week Skeletal Dynamics Data at ASBMR 2023

Retrieved on: 
Monday, October 16, 2023
European, Hypoparathyroidism, McMaster University, CHMP, PTH, Bone, Patient, Pathway, Parathyroid hormone, Southern Transcon, Research, Clinical trial, American Society for Bone and Mineral Research, Poster, Pharmaceutical industry, Medicine

COPENHAGEN, Denmark, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) shared 52-week data from the open-label extension period of its ongoing Phase 3 PaTHway Trial of TransCon PTH (palopegteriparatide) showing that adults with chronic hypoparathyroidism, whose bones tend to be over-mineralized due to insufficient parathyroid hormone (PTH) exposure, trended toward a new skeletal steady state closer to age-appropriate norms with continued use of TransCon PTH. The results were consistent regardless of sex, menopausal status, or duration of disease and were consistent with results previously reported through Week 110 in the Company’s Phase 2 PaTH Forward Trial.

Key Points: 
  • The results were consistent regardless of sex, menopausal status, or duration of disease and were consistent with results previously reported through Week 110 in the Company’s Phase 2 PaTH Forward Trial.
  • On September 14, 2023, TransCon PTH received a positive CHMP opinion recommending approval in the European Union for the treatment of adults with chronic hypoparathyroidism.
  • TransCon PTH is also in development in the United States and Japan.
  • Registered attendees of ASMBR 2023 conference can access the abstract, poster, and presentation (#1114) through the conference organizer’s website .

BridgeBio Pharma Announces New England Journal of Medicine Publication of Positive Encaleret Proof-of-Concept Phase 2b Results in Patients with Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Retrieved on: 
Tuesday, October 10, 2023
Annual general meeting, Calcium, Partnership, Walking, Cancer, Urine, Hypocalcemia, Research, PTH, The New England Journal of Medicine, Standard of care, Kidney failure, Society, American Society for Bone and Mineral Research, National Institute of Dental and Craniofacial Research, Vitamin D, Craniofacial, Kidney, Parathyroid hormone, Hypercalciuria, Hypercalcaemia, Bangladesh Technical Education Board, Blood, Endocrine Society, Patient, Quality of life, NIH, PALO, Pharmaceutical industry, Dietary supplement

“Conventional therapy for ADH1 includes raising the blood calcium levels with calcium supplements and activated vitamin D, taken in multiple doses throughout day.

Key Points: 
  • “Conventional therapy for ADH1 includes raising the blood calcium levels with calcium supplements and activated vitamin D, taken in multiple doses throughout day.
  • But this burdensome regimen may also increase urine calcium levels above normal, which can damage the kidney, leading to kidney failure in worst-case scenarios.
  • People with ADH1 need better treatments, so they are not constantly walking on a tightrope.
  • As part of the Phase 2b study, participants completed one or two 5-day inpatient dose-ranging periods, followed by a 24-week outpatient period.