FDA Approves Bonsity (teriparatide injection) to Treat Osteoporosis

In continuation of my update on teriparatide

Pfenex Inc. (NYSE American: PFNX) announced today that the U.S. Food and Drug Administration (FDA) has approved the new drug application (“NDA”) for Bonsity (PF708) submitted under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug. Like Forteo, the FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture. 

“The FDA’s approval of Bonsity marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfēnex Expression Technology platform. We look forward to continuing to work with our commercialization partner Alvogen to launch PF708 in the U.S. We believe PF708 has the potential to significantly enhance patient access to an important therapy as a cost-effective alternative to Forteo, which had $1.6 billion in global sales in 2018,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex.

Pfenex is also asking the FDA to designate PF708 as therapeutically equivalent (“A” rated) to Forteo, which would permit PF708 to be automatically substituted for Forteo in many states. To further support an “A” rating, Pfenex is conducting a comparative human factors study between PF708 and Forteo as requested by FDA. Pfenex anticipates submitting the final study report to the FDA as early as the second half of October 2019 and believes that this completes the information package required by the FDA to evaluate the therapeutic equivalence of PF708.

“Looking ahead, we are confident in the planning that Alvogen has done thus far in preparation for the commercial launch of PF708 and their established sales and marketing teams are excited to bring PF708 to market. To optimize patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating,” concluded Mr. Schimmelpennink.

https://en.wikipedia.org/wiki/Teriparatide

New protein supplement lowers cholesterol, prevents osteoporosis

Scientists developed a supplement to maintain optimal health that contributes to the growth and development of children and adolescents. It also prevents osteoporosis and certain cancers such as breast and prostate.

Prosoma is a protein supplement made from soy and amaranth, which contributes to lowering cholesterol and preventing osteoporosis, is inexpensive and was created by a group of students from the Interdisciplinary Center for Health Sciences (CICS) at the National Polytechnic Institute in Mexico City

Students Andrea Felix, Eva Fuerte, Ana Ramirez and Cesar Ramos, explained that proteins are made up of chains of amino acids, and are critical to maintaining good health as they contribute to the growth of children and adolescents, also help athletes to develop muscle and optimize their performance.

This food called Prosoma was made with soy and amaranth, vegetables that help lower cholesterol, prevent osteoporosis and certain cancers such as breast and prostate cancer, as opposed to commercial products, it contains no animal protein or chemical additives.

The team of students are specializing in Nutrition at the CICS and ensure that the mixture of these vegetables, added with small pieces of cranberry, form a functional food containing omegas 3 and 6, vitamins A, C, B1, B2 , B3, B6, K, folic acid, vitamins C and E, plus calcium, magnesium, iron, zinc, iodine, copper, selenium, phosphorus, potassium, fluorine and manganese.

According to the innovative development of Prosoma, it could help in combating malnutrition suffered by children between five and 12 years in some regions. It can be consumed by people of all ages, particularly those athletes who wish to strengthen their muscles.

New protein supplement lowers cholesterol, prevents osteoporosis

FDA Approves Duavee to Treat Hot Flashes and Prevent Osteoporosis

Bazedoxifene is a third generation selective estrogen receptor modulator (SERM), under development by Pfizer following the completion of their takeover of Wyeth Pharmaceuticals. Pfizer are seeking approval for bazedoxifene in the prevention and treatment ofpostmenopausal osteoporosis. Bazedoxfiene is the result of an exclusive research collaboration between Wyeth Pharmaceuticalsand Ligand Pharmaceuticals.

The U.S. Food and Drug Administration today approved Duavee (conjugated estrogens/bazedoxifene) for women who suffer from moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause....

FDA Approves Duavee to Treat Hot Flashes and Prevent Osteoporosis

Urocortin molecule protects cells from osteoarthritis, say researchers

We know that, Urocortin is a protein that in humans is encoded by the UCN gene. This gene is a member of the sauvagine/corticotropin-releasing factor/urotensin I family. It is structurally related to the corticotropin-releasing factor (CRF) gene and the encoded product is an endogenous ligand for CRF type 2 receptors. In the brain, it may be responsible for the effects of stress on appetite. In spite of the gene family name similarity, the product of this gene has no sequence similarity to urotensin II. Urocortin is a potent anorexigenic peptide of 40 amino acids that induces fed-like motor activity when administered centrally or peripherally in fasted animals. Urocortin belongs to the corticotropin-releasing factor (CRF) family that includes CRF, urotensin I, sauvagine, urocortin II and urocortin III. Urocortin is also a potent and long-lasting hypotensive agent and increases coronary blood flow.

Now researchers from The University of Manchester and the University of Westminster have found that the molecule, known as Urocortin, protects cells in the joints from being destroyed.

The discovery could help lead to the development of new medicines to prevent joint degradation  a condition which affects millions of people in the UK each year.

Common chemicals linked to osteoarthritis

Common chemicals linked to osteoarthritis

FDA Approves First Boniva Generics to Treat Or Prevent Osteoporosis

FDA Approves First Boniva Generics to Treat Or Prevent Osteoporosis: The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after

menopause. The most common type of bone disease...

Researchers discover allium vegetable consumption may lower hip osteoarthritis

Researchers discover allium vegetable consumption may lower hip osteoarthritis

Study indicates estrogenic drug could help treat schizophrenia

 

Study indicates estrogenic drug could help treat schizophrenia

Inhibition of serotonin synthesis in gut - a new way of treating osteoporosis ?

A crucial clue uncovered in Dr. Karsenty’s lab turned his attention to the small intestine, wherein his research team found that the gene Lrp5, (previously linked to a rare form of osteoporosis) controls the production of serotonin in the gut, and that serotonin is an inhibitor of bone formation. By inactivating Lrp5 in the small intestine of mice and thereby turning on the production of serotonin, bone mass decreased. While in contrast, the deletion of the same gene in the bone cells of mice, on the other hand, had no effect on bone mass. As per the claim by the researcher, these findings demonstrate that serotonin from the gut is acting as a hormone to regulate bone mass (1). 

Most osteoporosis drugs, including those currently under clinical investigation  do not generate new bone but prevent the breakdown of old bone and the only drug currently in  the market which can generate new bone   has its limited application (due to its reported increased risk of bone cancer,is restricted for short-term and  that too in women with severe osteoporosis). Researchers  read about an investigational drug, known as LP533401  which is able to inhibit serotonin in the gut they synthesized and used LP533401, a small molecule inhibitor of tryptophan hydroxylase-1 (Tph-1)  the initial enzyme in GDS biosynthesis.

Results demonstrated that osteoporosis was prevented from developing, or when already present, could be fully cured (in mice). Interestingly  levels of serotonin were normal in the brain, which indicated that the compound did not enter the general circulation and was unable to cross the blood-brain barrier, thereby avoiding many potential side effects. Dr. Karsenty and his colleagues did not find any gastrointestinal problems in mice unable to produce serotonin in their guts, suggesting that a serotonin inhibitor would not produce any such side effects in humans. The authors conclude that these results provide a proof of principle that inhibiting GDS biosynthesis could become a new anabolic treatment for osteoporosis.

Ref : http://www.nature.com/nm/journal/vaop/ncurrent/full/nm.2098.html

Bisphosphonates play a role in reducing recurrent breast cancer....

We know that bisphosphonates (also called diphosphonates) are a class of drugs that prevent the loss of bone mass, used to treat osteoporosis and similar diseases. Bone has constant turnover, and is kept in balance (homeostasis) by osteoblasts creating bone and osteoclasts digesting bone. Bisphosphonates inhibit the digestion of bone by osteoclasts. Osteoclasts also have constant turnover and normally destroy themselves by a process called cell suicide (apoptosis). Bisphosphonates encourage osteoclasts to undergo apoptosis. Though other uses like in he treatments of osteoporosis, osteitis deformans, bone metastasis, primary multiple myeloma,hyperparathyroidism and osteogenesis imperfecta were known. A new data suggests that these agents may play a role in reducing recurrent breast cancer as well. Zoledronic acid (see the structure) is both safe and effective in preventing bone loss in postmenopausal women with breast cancer who are treated with aromatase inhibitors, according to data presented at the CTRC-AACR San Antonio Breast Cancer Symposium. Women who take aromatase inhibitors need some sort of bone protection, and this five-year data show that zoledronic acid is a viable option.

As per the claim by the researchers lead by Dr. Adam Brufsky , women who are on Medicare tend to go with tamoxifen because the cost of anastrozole puts them squarely in the donut hole of Medicare Part D, but once the cost barrier is removed there will likely be a mass switch to the aromatase inhibitor, which will necessitate the need for bone protection. More interestingly, in the same conference a research group lead by Rowan Chlebowski presented a study wherein "women who used bisphosphonates, had significantly fewer invasive breast cancers than women who did not use bisphosphonates. .......

http://www.upci.upmc.edu/news/upci_news/121009_study.cfm

Steroid-induced osteoporosis can now be treated with Teriparatide

Steroid-induced osteoporosis can now be treated with Teriparatide

Fabled 'Vegetable Lamb' Plant Contains Potential Treatment For Osteoporosis

Fabled 'Vegetable Lamb' Plant Contains Potential Treatment For Osteoporosis

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