The first topically applied drug for treatment of erectile dysfunction (ED) has been approved by regulatory body the European Decentralised Procedure.

Vitaros (alprostadil) cream from Takeda is now expected to gain MHRA approval for use in the UK within three months.

It will provide an alternative for many male patients who cannot tolerate PDE5 inhibitor drugs such as Viagra (sildenafil).

ED is a common consequence of ageing and several long-term conditions, and is also a common side effect of drugs such as anti-depressants and anti-hypertensives.

Vitaros is a vasodilator, boosting local blood flow at the application site, whereas oral ED drugs affect the whole circulation – often with negative side-effects.

A clinical trial in over 3,300 patients showed that topical alprostadil cream was generally well tolerated, with most side-effects being mild and of short duration – in contrast to many patients’ experience of PDE5 inhibitors.

Topical administration of Vitaros is enabled by the proprietary skin permeation-enhancing drug delivery platform NexACT, licensed by Takeda from NexMed.

“This is great news for Takeda UK and for the many men living with erectile dysfunction, and we are delighted that the UK approval of this new treatment should now be just a few months away,” said Yasuhiro Fukutomi, Managing Director, Takeda UK Ltd.

“This is an innovative new product that offers the potential to provide men with a new first line or alternative treatment option. Vitaros has been shown in clinical trials to provide rapid efficacy together with convenient local administration that is well tolerated. Takeda UK Ltd envisages that it will be a significant addition to our urology franchise.”

The first advance in the treatment of bone cancer in children and young people in two decades has been recommended in final guidance by NICE.

Takeda’s Mepact (mifamurtide), in combination with postoperative multi-agent chemotherapy, has been made available to the NHS at a reduced cost under an agreed Patient Access Scheme (PAS).

Sir Andrew Dillon, NICE Chief Executive, says for those treated with Mepact “the health benefits continue over the rest of their lives, effectively being a cure”.

The appraisal saw NICE for only the second time in its history clarify its ‘methods guide’ for treatments which can restore health over a long period, and together with the PAS, reduced the cost per QALY of Mepact.

“Following a clarification from the NICE Board on this issue, and in addition to a revised patient access scheme from the manufacturer, the extra cost per unit of health gained that the NHS will pay for mifamurtide is now lower than previously determined, but still above the normal range that is usually accepted,” said Sir Andrew.

“After having looked again very carefully at a number of factors (such the curative potential of the drug for some people and the small patient population) and taking these factors into account, the Committee was able to recommend mifamurtide for osteosarcoma as a cost-effective use of NHS resources.

“Today’s recommendation of mifamurtide will help children and young people with this very painful and distressing disease, as well as providing some for hope for them, and the people caring for them.”

NICE initially failed to recommend the treatment in an FAD published in October last year. However, after the revision to its methods guide and the proposed PAS, Yasuhiro Fukutomi, Managing Director of Takeda UK, says the company is delighted with the outcome.

“We are grateful to all those who have been involved in this long process including those at NICE, the Department of Health, physicians and patient organisations,” he said. “It has taken everyone’s collaboration to lead us to this successful conclusion for osteosarcoma patients today.”

Mepact was recommended by NICE in draft guidance in September and was approved for use in Scotland in August 2011.

NICE has recommended Takeda’s Mepact (mifamurtide) as a treatment option for osteosarcoma when made available under an agreed patient access scheme in draft guidance.

A similar appraisal last year failed to recommend the drug for bone cancer, but, after clarification from NICE’s Board on how discounting is applied, its Appraisal Committee has now given the treatment the green light.

Sir Andrew Dillon, NICE Chief Executive, says the appraisal has raised “some important methodological issues” but after “careful consideration” the Committee recommended its use.

Evidence supplied by Takeda indicated that Mepact, when added to standard treatment with surgery and chemotherapy, increases the number of patients who are effectively cured of bone cancer.

The clarification from the Board provided guidance on how discount rates can be applied in this circumstance, and, having noted this – and taken all other aspects into account, the Committee concluded the drug “could be accepted as a cost-effective use of NHS resources”.

Yasuhiro Fukutomi, Managing Director of Takeda UK, thanked “all those who have been involved in this long process including those at NICE, the Department of Health, physicians and patient organisations”. He added: “It has taken everyone’s collaboration to lead us to this successful conclusion for osteosarcoma patients today.”

Mepact has demonstrated it can reduce the risk of death from bone cancer in children and young adults by almost a third and is the first advance in the treatment for osteosarcoma for 20 years, the company says.

NICE initially produced final draft guidance in October last year which was unable to provisionally recommend the treatment in combination with post-operative chemotherapy drugs for the treatment of high-grade non-metastatic, surgically treatable bone cancer.

Takeda’s Mepact has won approval from the SMC for the treatment of high grade non-metastatic osteosarcoma in children, adolescents and young adults aged between 2 and 30.

Following a resubmission Mepact will now be available to all eligible patients on NHS Scotland after it was shown to reduce the risk of death by almost a third.

Yasuhiro Fukutomi, Managing Director of Takeda UK, says the company has “always been committed” to achieving a “successful conclusion for osteosarcoma patients in Scotland”.

Osteosarcoma is a rare and often fatal form of bone cancer with approximately 150 new cases in the UK each year.

There have been no medical advances in the treatment of the condition in the last two decades. Current treatment is chemotherapy given before and after the tumour has been surgically removed (resection).

But for up to a third of newly diagnosed patients the cancer will return after surgery and standard chemotherapy, and between a third and half of all children and young adults will not survive beyond five years of being diagnosed.

Roger Paul, Chairman of the Bone Cancer Research Trust, welcomed the SMC’s decision.

“This is a fantastic result which means that children and young adults in Scotland have access to this treatment that has been shown to improve long-term survival in a large clinical trial,” he said.” There is strong support for Mepact from clinicians, patient groups, patients and their families alike, and the SMC’s recognition of the potential clinical benefits of Mepact is welcomed.”