Custom Search

Wednesday, October 13, 2010

New drug containing enzyme that can lower uric acid level in gout gets US FDA approval

New drug containing enzyme that can lower uric acid level in gout gets US FDA approval

Krystexxa is a drug containing an enzyme pegloticase that can reduce uric acid levels by metabolizing uric acid in to harmless molecules which are readily excreted in the urine thus preventing the building up of uric acid concentration in our body. The drug is required to be administered to patients after every two weeks as an intravenous infusion.

Enzyme pegloticase is synthesized by using recombinant technology , where DNA of micro-organisms are genetically engineered so that they synthesize desired proteins , here it is pegloticase and human insulin too is synthesized by using this technology .

The enzyme pegloticase is further reacted with polyethylene glycol to form a covalent bonds between enzyme-Polyethylene glycol which is also known as peglytation so as to increase half-life of enzyme and make it available for longer duration for its desired action in body, this process can reduce the presentation of antigenic properties to body’s immune system , rendering the molecule lesser antigenic or reduce its immunogenicity. The process of formation of covalent bonding with PEG is known as PEGylation

Gout is a painful disease condition a where needle like crystals of uric acid get deposited in joints or in soft tissue , these crystals serve as a continuous painful sensation in joints or in soft tissue and at locations where ever they get deposited. These uric acid crystals cause intermittent swelling, redness, heat, pain and stiffness in the joints resulting in to a painful condition.

Uric acid crystals deposition (Gout ) occurs due to excess uric acid concentration in our body , which result from imbalanced metabolism of our body resulting in to high blood level of uric acid , which is normally associated with associated with obesity, high blood pressure, high cholesterol and diabetes, and occurs more often in men, in women after menopause, and in people with kidney disease.

The U.S. F DA has approved Krystexxa (pegloticase) to treat gout, a painful condition in adults who do not respond to or who are not able to tolerate other drug therapies.

Almost three percent of the three million adults suffering from gout do not get benefit from conventional therapy for gout, which is focused with administration of a drug that lower the amount of uric acid in the blood, like xanthine oxidase inhibitors Zyloprim (allopurinol) and Uloric (febuxostat).

Clinical trials:
It is observed in two six-month clinical trials where in 212 total patients on drug Krystexx were able to lower uric acid levels and reduced deposition of uric acid crystals in joints and soft tissue.

Allergic reactions:
Almost one patient out of every four patients participated in Krystexx clinical trial experienced a severe allergic reaction while receiving an infusion of Krystexxa, hence it is advised that health care providers should dispense a corticosteroid and an antihistamine to their patients beforehand to minimize the risk of allergic reaction. Other reactions observed during the clinical trials are gout flare, nausea, injection site bruising, nasal passages irritation, constipation, chest pain and vomiting.

Physicians too are warned to be cautious while administering Krystexxa to patients with congestive heart failure as the drug was not studied in this group of patients.

US FDA has approved drug Krystexxa with a Risk Evaluation and Mitigation Strategy (REMS) that requires to includes a medication guide for patients and materials for healthcare providers to communicate the risk of severe allergic reactions during and after infusion of Krystexxa.

Contraindications
Krystexxa is contraindicated in patients with Glucose-6-phosphate dehydrogenase (G6PD) Deficiency:
Hence before Krystexxa treatment, patients should be screened for for G6PD deficiency (e.g., those of African and Mediterranean ancestry) as there is a risk of hemolysis and methemoglobinemia.

Krystexxa is manufactured by pharmaceutical company, Savient Pharmaceuticals Inc. of East Brunswick, N.J. USA

=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.

=====================================================================================================
You may also like following articles

Whar is Referance Listed Drug  ? ( RLD )

What is Pharmaceutical Equivalents

What is Pharmaceutical Alternatives

What is Therapeutic Equivalents


Do Physical properties contribute to drug activity.

What is drug receptor , How a drug resistance occurs

Mechanism of drug resistance

What is drug interaction

Drug interaction, and its examples

What is first pass metabolism of a drug

What is What is 510(k) Clearances ?

What is 510(k) Clearances,

Premarket Notification for medical devices - PMN or 510(k)

What is a drug interaction

Examples of drug interactions


Antibiotic Definition and classification


Antibiotic resitance and Antibiotic resistance mechanism

Antioxidants food suppliments

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D


What is an antibody? what is monoclonal and polyclonal antibodies?

Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production

TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry

Find a Job in Pharmaceutical Company
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company

1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industryan explanation

No comments:

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org