Archive for the ‘Immunosuppressant’ Category

Daclizumab Passes Phase III Hurdles

Thursday, July 3rd, 2014

DaclizumabExciting news has been shared by Abbvie and Biogen regarding Daclizumab and it’s now brighter future. The once a month treatment for MS has now cleared all major Phase III hurdles, making a marketing pitch to FDA regulators foreseeable in the near future. As an injectable medication designed to combat the debilitating symptoms of Multiple Sclerosis, or MS, Phase III results demonstrated a 45 percent drop in the yearly relapse rate for the patients who received Daclizumab. This percentage is statistically significant for a CD25 blocker. Additionally, Daclizumab sizably reduced the number of new enlarging T2 hyperintense lesions. This occurred at approximately 96 weeks into the study, showing a 54 percent reduction as compared to competitor Avonex. While there were several adverse effects, such as serious infections and cutaneous reactions the vast majority of the 1,800 participant study did very well.

CD40L ExpressionDaclizumab has proven to be an efficacious treatment for Multiple Sclerosis, as it inhibits the survival of activated T cells as well as CD40L expression. The administration of Daclizumab also decreases the amount of circulating lymphoid cells, which are usually elevated in patients who have not yet received treatment for MS. The SELECT study of Daclizumab, which was published in 2013, demonstrated the power of this drug as a humanized monoclonal antibody of IgG1 subtype. The design of Daclizumab to act as a therapy which selectively inhibits the T-cell activation makes this formidable treatment unstoppable. By inhibiting organ inflammation, activating immunoregulatory CD56 NK cells and modulating the development of innate lymphoid cells Daclizumab is proving to be an advantageous and effective treatment broad spectrum. Continued research and development is underway to ultimately gain the FDA approval for this phenomenal drug.

LGM Pharma is a provider of API Daclizumab, CAS 152923-56-3 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

FDA Accepts of NDA for Autopen Containing Methotrexate

Thursday, February 20th, 2014

MethotrexateThe culmination of the month of January 2014 brought good news for Medac Pharma regarding their innovative Methotrexate autopen. This easy to use, novel, self-injectable device was accepted as a New Drug Application (NDA) by the FDA. As a subcutaneous injectable form of Methotrexate, the autopen is a ready to use device geared for patients with rheumatoid arthritis, psoriasis and poly-articular-course juvenile rheumatoid arthritis. In addition to the convenience of a simple injectable treatment that patients with debilitating conditions like rheumatoid arthritis can utilize with ease, the Methotrexate autopen can be customized for dose specific drug volumes. The painful and incurable symptoms of autoimmune diseases like rheumatoid arthritis, poly-articular-course juvenile rheumatoid arthritis and psoriasis require a lifetime of treatment for the vast majority of patients. By utilizing a handy autopen with customizable dosages of Methotrexate the patients suffering from these inflammatory autoimmune conditions have the opportunity for increased mobility, convenient administration and personalized dosing.

Methotrexate works effectively by reducing the inflammation associated with rheumatoid arthritis and slowing the progression of the disease. As a disease-modifying antirheumatic drug Methotrexate is also considered to be an immunosuppressive medication. Methotrexate is one of the most commonly used treatments for rheumatoid arthritis, as adverse effects from this this drug are few. Statistics show that over half of the patients who are administered Methotrexate to treat their symptoms of rheumatoid arthritis continue to take this medication faithfully for at least three consecutive years. This data indicates that this is the longest time for patient medication adherence when compared to other best in care medications for RA. The advent of the autopen will only increase the number of patients adhering to their medication schedule, and reaping the benefits of this formidable drug.

LGM Pharma provides Methotrexate CAS# 59-05-2, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

EU Approves Dimethyl Fumarate for First Line MS Treatment

Monday, February 17th, 2014

Dimethyl Fumarate EU ApprovalDimethyl Fumarate was approved by the EU at the beginning of February 2014 as a first line treatment for multiple sclerosis. Known as the brand name TECFIDERA, which is marketed by Biogen Inc., this efficacious and novel treatment is specified for patients with the most common form of multiple sclerosis, relapsing-remitting multiple sclerosis, or RRMS. Dimethyl Fumarate is thought to work effectually by successfully activating the Nrf2 pathway, which in turn offers a viable pathway for cells in the body to defend themselves from both oxidative stress and inflammation from RRMS. The safety and tolerability of the Dimethyl Fumarate has been positive, as these hard capsules are designed to be gastro-resistant. The standard starting dose of Dimethyl Fumarate  is 120 milligrams, administered twice a day for seven days. After the initial full seven day week the patient is typically dosed with an increased amount of Dimethyl Fumarate , specifically 240 milligrams twice daily. Adverse side effects have been uncommon in study participants, as well as in aftermarket clinical data. Common negative effects from Dimethyl Fumarate include mild nausea, diarrhea, upper abdominal pain and flushing. Dimethyl Fumarate {TECFIDERA} has been the number one prescribed oral therapy for MS and RRMS in the United States since it’s FDA approval in March of 2013. This powerhouse therapy has also been approved in Canada and Australia since mid-2013.

myelin-sheathClinical trials of Dimethyl Fumarate {TECFIDERA} have proven to be palmy and operative for patients with both RRMS and MS in general. Not only does treatment with Dimethyl Fumarate aid patients in the reduction of relapses of debilitating symptoms, it also reduces the incidence of brain lesions and alleviates the overall progression of this devastating condition.  Encouraging and fruitful data from two large Phase 3 clinical studies of Dimethyl Fumarate  were the catalyst for the EU approval earlier this month. The duo of trials, coined CONFIRM and DEFINE also  encompassed an additional extension study deemed ENDORSE, which followed a number of patients with MS for almost six and a half years. In the study DEFINE patients received Dimethyl Fumarate twice daily according to the standard, best in care dosing schedule. Results from this patient population indicated significant reduction in the proportion of patients who relapsed by roughly 49 percent. The CONFIRM study also produced extremely encouraging results, showing that as compared to a placebo the patients who were dosed with Dimethyl Fumarate displayed greatly reduced relapse rates at the two year mark, and also offered a 21 percent reduction in disability progression at the 12 week point. Further data analyzed by researchers gleaned even more hopeful results, showing that in both of the aforementioned studies patients who were given  Dimethyl Fumarate  had sizable reductions in brain lesions, as compared to the placebo group.

LGM Pharma provides Dimethyl Fumarate, CAS# 624-49-7, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Eculizumab Receives Orphan Drug Status

Thursday, February 13th, 2014

EculizumabAt the end of January 2014 the powerful drug Eculizumab received orphan drug status from the FDA as a preventative treatment of delayed graft function (DGF) for renal transplant patients. Known as the brand name Soliris, which is marketed by Alexion Pharmaceuticals, Eculizumab is already approved to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Paroxysmal nocturnal hemoglobinuria or PNH is a rare form of anemia that until the approval of Eculizumab in 2007 was untouchable in terms of viable treatment options for patients with this atypical disease. Additionally, Eculizumab was approved to treat atypical hemolytic uremic syndrome, or aHUS, which is an extremely uncommon kidney disorder affecting roughly one in every million people worldwide.

Eculizumab {Soliris) has provided a beacon of hope for patients suffering from rare disorders, and the latest orphan drug status from the FDA demonstrates the continued benefits of this innovative drug. The National Organization for Rare Disorders supports the use of the monoclonal antibody Eculizumab and offers financial assistance for this drug for patients with financial hardship.

The latest FDA nod for Eculizumab for its use after a kidney transplant  offers patients options for safe and effectual treatment should they experience delayed graft function post- surgery. DGF is a common problem for kidney transplant patients, and it often occurs soon after surgery is complete. When DGF occurs the transplanted organ does not immediately begin functioning normally, thus leading to the unfortunate need for lifelong dialysis for the patients. However, the use of Eculizumab in kidney transplant patients, as well as other solid organ transplant patients, has been shown to inhibit the terminal complement pathway and effectively lower the risk of DGF.

The typical dosage for Eculizumab is dispensed post-transplant surgery once a week for five consecutive weeks, and then once every two weeks. The length of time a patients receives Eculizumab is determinate on their specific medical condition, physical well-being and their type of transplant surgery. As an I.V. infusion Eculizumab is dispensed in a hospital or healthcare setting. Adverse effects are not common, and typical side effects from Eculizumab include headache, nausea and diarrhea.

LGM Pharma provides Eculizumab CAS# 219685-50-4, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

Thalidomide Offers Effectual Treatment for a Variety of Conditions

Monday, December 16th, 2013

ThalidomideThalidomide, known as the brand name Thalomid, is a known therapy for patients who are newly diagnosed with multiple myeloma. Patients who have been recently diagnosed with multiple myeloma are often given a combination treatment of Thalidomide and dexamethasone.

Recently, research has shown that there are new possible uses for Thalidomide to treat a variety of conditions. The Journal of the American Medical Association reported positive findings from a study published on November 26, 2013 about the use of Thalidomide for Crohn’s disease. This study included an 8 week trial to assess the use of Thalidomide for children and adolescents who had unresectable Crohn’s disease which had not responded to previous best in care treatments. This clinical trial was held in Italy and involved 56 patients who were either children or adolescents. The young patient population was randomized to receive either Thalidomide or a placebo one time a day for eight weeks total.  The patients who were administered with Thalidomide had a significantly greater chance of remission in comparison to the group of patients who were dosed with a placebo. Of the 49 children who were administered with Thalidomide 63.3% achieved a status of clinical remission at the eight week mark of the study. Additionally, 65.3% of the children and adolescents who were given Thalidomide experienced a 75% response rate.

crohns diseaseWith roughly half a million people in the United States suffering from Crohn’s disease the information gleaned provides a glimmer of hope for the youngest patients suffering with this debilitating condition. One quarter of all people diagnosed with Crohn’s disease develop their initial symptoms as children, which often become severe as they reach adulthood and become resistant to traditional therapies.

Thalidomide is also an effectual drug approved to treat inflammatory diseases of the skin and mucous membranes, like as an acute treatment for patients with severe erythema nodosum leprosum (leprosy), also known as ENL. This specific patient group with ENL should have a moderate to severe cutaneous manifestation, and Thalidomide is not advised as a monotherapy if the patient has either moderate or severe neuritis. Thalidomide is recommended as a preventative maintenance therapy for the suppression of ENL cutaneous manifestations as well. Research is currently underway to examine whether Thalidomide is also efficacious for treating other skin conditions, such cutaneous lupus,  Behcet’s disease, and HIV-related mouth and throat ulcers.

LGM Pharma provides the API Thalidomide, CAS# 50-35-1, for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.