AmeriPharmTimes

Teriparatide Injection, Representation image only

Almaject gets FDA approval for Teriparatide

Teriparatide
is a medication used in the treatment of osteoporosis. It is a recombinant form
of parathyroid hormone, specifically the first 34 amino acids, and is marketed
under the brand name Forteo. Teriparatide is administered via daily subcutaneous
injection and works by stimulating new bone formation, increasing bone mineral
density, and reducing the risk of fractures in patients with osteoporosis. It’s
typically prescribed when other osteoporosis treatments have not been effective
or are not suitable for the patient.

This drug
recently in June 2024 has got approval on NDA filed by the manufacturing
company named Almaject Inc, which is US subsidiary of Alvogen. Almaject is
dedicated spin-off company of Alvogen focused on manufacturing commercial
injectable generic pharmaceutical products.

The New Drug
Application filed to FDA has mention about the use as:

·        
Treating postmenopausal women with osteoporosis
who are at high risk for fractures, either because they’ve already had
osteoporotic fractures or they have multiple risk factors for fractures. It’s
also for those who haven’t responded well to other osteoporosis treatments or
can’t tolerate them.

·        
Increasing bone mass in men with primary or
hypogonadal osteoporosis who are at high risk for fractures or who haven’t
responded well to other osteoporosis treatments.

·        
Treating both men and women who have osteoporosis
caused by long-term use of systemic glucocorticoid therapy (like prednisone at
a daily dose of 5 mg or more) and who are at high risk for fractures or who
haven’t responded well to other osteoporosis treatments.

 

The Reference drug listed and reference standard drug used in the
NDA was FORTEO manufacture by ELI LILLY AND CO. Other
companies manufacturing bioismilar injections to FORTEO are Alvogen Inc
manufacturing it with Brand name- BONSITY, Apotex and Teva pharmaceuticals with
generic name – Teriparatide.

Approved by the FDA,
this medication plays a crucial role in managing this debilitating condition,
particularly in postmenopausal women, men at high risk of fractures, and
individuals with glucocorticoid-induced osteoporosis.

Osteoporosis,
characterized by weak and brittle bones, significantly increases the risk of
fractures, leading to severe health complications and reduced quality of life.
Teriparatide works by stimulating new bone formation, contrasting with most
other osteoporosis treatments that only slow bone loss. It mimics the natural
parathyroid hormone, promoting the activity of osteoblasts, the cells
responsible for bone formation. This dual action—enhancing bone formation and
improving bone density—makes Teriparatide an effective intervention for
patients with severe osteoporosis.

Administered as a daily
subcutaneous injection, Teriparatide is typically prescribed for a treatment
duration of up to two years. Patients are trained to self-administer the
injection, often into the thigh or abdomen. This treatment has been shown to
significantly increase bone mineral density and reduce the risk of vertebral
and non-vertebral fractures, offering a promising option for those who have not
responded adequately to other osteoporosis therapies.

While Teriparatide is
generally well-tolerated, potential side effects include nausea, dizziness, leg
cramps, and injection site reactions. Long-term use is limited due to concerns
about the potential risk of osteosarcoma, a rare bone cancer, observed in
animal studies. However, this risk has not been observed in humans at
therapeutic doses.

Healthcare providers
consider the benefits of Teriparatide against its risks, making it a valuable
option for patients with severe osteoporosis or those who cannot tolerate other
treatments. Regular monitoring and follow-up are essential to ensure the
effectiveness and safety of the therapy.

In summary,
Teriparatide injection represents a significant advancement in the treatment of
osteoporosis in the USA, offering hope to many individuals at high risk of
fractures and contributing to improved bone health and quality of life.

Cite this: Almaject gets FDA approval for
Teriparatide- AmeriPharmTimes – Jul, Issue (1), 2024.

 

Rytelo Injection, Representation image only