NICE Approves GlaxoSmithKline plc (ADR)(NYSE:GSK) Gene Therapy Strimvelis

GlaxoSmithKline Plc

The healthcare cost watchdog in Britain, NICE – National Institute for Health and Care Excellence, has given approval for a gene therapy developed by GlaxoSmithKline plc (ADR)(NYSE:GSK) for the treatment of adenosine deaminase deficiency, Strimvelis. According to NICE, Strimvelis offers an improvement in the overall survival rate in patients who have the condition in comparison with other therapies such as stem cell transplants. This is the second time a gene therapy is being licensed in the world for the treatment of an inherited disease.

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Adenosine deaminase deficiency is inherited and patients suffering from the condition have to be placed in isolation in order to prevent them from getting infections since the disease disables the patient’s immune system. Patients usually die in adolescence.

Life-long treatment

The Strimvelis gene therapy will be offered at a price of $700,000 for a life-long treatment. This is almost the same as the combined costs incurred with alternative treatment provided by other drugmakers.

“Strimvelis represents an important development in the treatment of ADA-SCID, offering the potential to cure the immune aspects of the condition and avoid some of the disadvantages of current treatments,” said NICE in a statement.

With the Adenosine deaminase deficiency being an extremely rare condition, the gene therapy treatment will be offered in a Milan hospital, which is the only facility in the world providing the treatment.

Shingles vaccine

The approval of Strimvelis by the National Institute for Health and Care Excellence comes at a time when GlaxoSmithKline’s shingles vaccine for adults who are aged 50 and over, Shingrix, has been approved by the U.S. Food and Drug Administration. Shingrix is administered as an injection in order to prevent the infection which results in a painful rash. In the United States shingles affects about a third of the population.

Prior to the Food and Drug Administration granting the approval, a phase 2 clinical trial had been conducted on participants numbering over 38,000. The trial results demonstrated that the vaccine was effective against Shingles 90% of the time in all ages. The vaccine was also effective even after four years.

Besides preventing the occurrence of shingles, the incidences of postherpetic neuralgia, a complication which is associated with shingles and whose symptoms include chronic nerve pain. Following the approval granted by the FDA the Advisory Committee on Immunization Practises of the U.S. Centers for Disease Control and Prevention will vote on Shingrix use this week.

On Friday shares of GlaxoSmithKline fell by 0.61% to close the day at $40.84.

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