US FDA approves GlaxoSmithKline's Jalyn for symptomatic BPH; fast tracks Genzyme's MS drug alemtuzumab

The US Food and Drug Administration yesterday approved UK drug giant GlaxoSmithKline's Jalyn, a single-capsule combination of dutasteride (0.5mg) and tamsulosin (0.4mg) to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. GSK expects to make the product available during the second half of 2010.

'This is the first time these therapies will be available together in a once-daily capsule,' said Anne Phillips, vice president, R&D medicine development leader at GSK, noting that 'Jalyn offers two mechanisms of action to provide symptom improvement and the ability shrink the prostate over a sustained time.'

Approval of the combination was based on two-year results from the CombAT (Combination of Avodart and Tamsulosin) study, one of the largest clinical trials to date of men with BPH (4,844 patients). The study compared changes in urinary symptoms seen with dutasteride co-administered with tamsulosin as opposed to either medicine alone. Changes were measured via a validated symptom index. Reported adverse events were consistent with the known safety profiles of dutasteride and tamsulosin. The most common adverse reactions reported in subjects receiving combination therapy were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders and dizziness, GSK noted.