The Japanese launch of a new drug designed to tackle genetic hair loss in men has been delayed indefinitely after irregularities in production were discovered at a French manufacturing facility.
The drug, Zagallo (dutasteride) was being manufactured for GSK’s Tokyo-headquartered subsidiary GlaxoSmithKline K.K. by global pharmaceutical company Catalent at a facility in Beinheim in France. According to writer Gareth MacDonald, reporting for in-pharmatechnologist.com, the drug had been approved for treatment of Male Pattern Hair Loss by Japanese regulators in September 2015 after encouraging results in a clinical trial.
Not licenced by MHRA
Based on the proven and popular daily male hair loss tablet finasteride 1mg, dutasteride features this active ingredient to help to block the formation of DHT, the testosterone by-product which causes hair loss in those with a predisposition towards the condition, but in much larger 5mg doses.
In 1992, Proscar, a drug similar to dutasteride that also contains 5mg of finasteride as its active ingredient, was licensed for men aged 60+ in the UK for the prevention of Benign Prostate Hyperplasia (BPH). However, neither drug is currently licensed as a male hair loss treatment by the UK’s MHRA nor approved for this use by America’s FDA.
Tests showed that traces of dutasteride would stay in the body for more than a month after it has stopped being taken. This is far longer than finasteride 1mg which has a much shorter “half-life” (a way to measure the time a drug takes to leave the body) of one week. It is possible, of course, that the Japanese manufacturers have refined the drug to reduce its half-life, although whether they have or not is currently unknown.
Production halted due to irregularities
Production of Zagallo ground to a halt after “out-of-place softgel capsules in several product batches were detected during quality control procedures.” They were removed prior to distribution to patients.
According to Catalent’s website: “The company’s preliminary investigation indicates that it is highly unlikely that the capsules could have been placed incorrectly through unintentional human error or from failure of a control process, and that the incidents could be potentially related to a deliberate action by one or more individuals.”
As with all new hair loss developments, Belgravia was keen to monitor the progress of Zagallo and whether its release leads to further trials of the drug or biosimilars in the UK – but it looks like there will now be a delay before progress resumes.
Androgenic Alopecia is the number one cause of hair loss worldwide, affecting millions of men, many of whom want to try to fight their general thinning, or receding hairline.
At Belgravia, comprehensive hair loss treatment courses featuring clinically-proven components, such as high strength minoxidil, and hair growth boosters are personally-tailored to each client’s individual needs in order to produce their optimum regrowth results.
The Belgravia Centre
The Belgravia Centre is the leader in hair loss treatment in the UK, with two clinics based in Central London. If you are worried about hair loss you can arrange a free consultation with a hair loss expert or complete our Online Consultation Form from anywhere in the UK or the rest of the world. View our Hair Loss Success Stories, which are the largest collection of such success stories in the world and demonstrate the levels of success that so many of Belgravia’s patients achieve. You can also phone 020 7730 6666 any time for our hair loss helpline or to arrange a free consultation.