Romiplostim for ITP (FDA 2008)

Romiplostim is an antihemorrhagic. This member of the thrombopoietin (TPO) mimetic class is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl), a mechanism analogous to endogenous TPO.

Romiplostim is specifically indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

Romiplostim is supplied as sterile solution (250 mcg and 500 mcg) designed for subcutaneous administration.The recommended initial dose of the drug is 1 mcg/kg once weekly based on actual body weight, as a subcutaneous injection.

Source:centerwatch

Rufinamide - FDA 2009

Rufinamide is a triazole derivative. The exact mechanism of action is unknown. However, it is thought that rufinamide modulates the activity of sodium channels and, in particular, prolongation of the inactive state of the channel.

Rufinamide is specifically indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults.

Rufinamide is supplied as a 200mg or 400mg tablet for oral administration.

source:centerwatch

Telavancin-New dual role antibiotic (FDA 2009)

Telavancin is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby Vibativ both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.

Telavancin is specifically indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates),Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only).

Source:centerwatch

Tesamorelin (FDA 2010)

Tesamorelin, an analog of human growth hormone-releasing factor (GRF). Tesamorelin binds and stimulates human GRF receptors with similar potency as the endogenous GRF. Growth hormone-releasing factor is a hypothalamic peptide that acts on the pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone, which is both anabolic and lipolytic.

Tesamorelin is specifically indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.

Source:centerwatch

Lurasidone for schizophrenia (FDA approved 2010)

Lurasidone is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. The mechanism of action of lurasidone is unknown, however has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 (D2 ) and serotonin Type 2 (5HT2A) receptor antagonism.
Lurasidone is supplied as a tablet for oral administration. The recommended starting dose is 40 mg once daily and the maximum recommended dose is 80 mg/day. Lurasidone should be taken with food (at least 350 calories). Dose adjustments are recommended for the following: patients with moderate and severe renal impairment, patients with moderate and severe hepatic impairment, patients taking concomitant potential CYP3A4 inhibitors and patients taking concomitant potential CYP3A4 inducers


Source:centerwatch

Ulipristal acetate FDA approved (2010) for emergency contraception

Ulipristal acetate is a synthetic progesterone agonist/antagonist. When taken immediately before ovulation is to occur, Ulipristal postpones follicular rupture. The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy.It reversibly blocks the progesterone receptor in its target tissues (uterus, cervix, ovaries, hypothalamus) and acts as a potent, orally active anti-progestational agent.

Ulipristal  is specifically indicated as an emergency contraceptive for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

Ulipristal  is supplied as a tablet for oral administration. The recommended dose is one tablet taken orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure.

source:centerwatch

Fingolimod (approved by FDA in 2010) in multiple sclerosis

Fingolimod is a sphingosine 1-phosphate receptor modulator and binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5.Fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system.

Velaglucerase alfa (appoved by FDA) in 2010

Velaglucerase alfa:

 Gaucher disease, caused by deficiency of the enzyme glucocerebrosidase, results in accumulation of a toxic glycolipid substrate, called glucocerebroside. Velaglucerase alfa supplements or replaces beta-glucocerebrosidase, the enzyme that catalyzes the hydrolysis of glucocerebroside, reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease.

source:centerwatch.com

Unexpected New Mechanism Behind Rheumatoid Arthritis

A team of researchers at the University of Gothenburg, Sweden, has identified an enzyme that protects against inflammation and joint destruction. Made when the researchers blocked production of the enzyme GGTase-I in transgenic mice, this unexpected discovery could lead to the identification of new mechanisms that control the development of inflammatory disorders, as well as new medicines


Description:
GGTase-I is found in all cells but is particularly important for the function of so-called CAAX proteins in inflammatory cells. GGTase-I attaches a cholesterol-like fatty acid on the CAAX proteins.

Researchers previously believed that this fatty acid played an important role in activating the proteins and could contribute to the functioning of inflammatory cells. There are now medicines that include substances that suppress the activity of GGTase-I with the aim of stopping the CAAX proteins from working.


Current use:
 These substances are already being clinically tested on cancer patients, and researchers have also wondered whether they could be used to alleviate inflammatory disorders such as rheumatoid arthritis


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