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.

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

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