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HIV prevention pill heads July CHMP recommendations

Gilead’s Truvada given positive opinion alongside Ipsen Pharma’s Cabometyx and Eisai’s Kisplyx

EMAThe EMA's advisory committee has backed the approval of Gilead's Truvada as the first HIV prevention regimen.

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Truvada (emtricitabine/tenofovir disoproxil) as pre-exposure prophylaxis (PrEP) - in combination with safe sex practices - to reduce the risk of HIV infection in uninfected high-risk adults.

Truvada was first approved by the EMA in 2005 and is currently the most prescribed antiretroviral medicine in Europe as part of HIV combination therapy. The company says having an approved PrEP regimen could have a significant public health impact in helping to lower HIV transmission rates in Europe.

Gilead is in the process of rolling out a new version of the drug - called Descovy - based on an improved tenofovir salt and was approved in the EU in April.

Truvada was one of several medicines backed by the CHMP at its monthly meeting last week. The panel also recommended approval of two targeted kidney cancer medicines - Ipsen Pharma's Cabometyx (cabozantinib) and Eisai's Kisplyx (lenvatinib) - which are both tyrosine kinase inhibitors being developed for advanced renal cell carcinoma.

Both Cabometyx and Kisplyx have been given an accelerated assessment by the EMA for advanced RCC patients who have previously been treated with a VEGF inhibitor, with Ipsen's drug backed as a monotherapy while Eisai's is intended for use in combination with everolimus.

The two active ingredients have previously been approved as therapies for thyroid cancer in the EU. Cabozantinib was approved for this indication under the Cometriq brand name in late 2013, while lenvatinib got the nod last year as Lenvima.

Originally developed by Exelixis, cabozantinib was licensed by Ipsen in a $855m deal announced in February.

The CHMP also gave a positive opinion for Shire's Onivyde (pegylated irinotecan liposomal formulation) for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin, in adults whose disease has progressed after gemcitabine-based therapy.

The drug could provide a new treatment option for a patient group that has not seen much improvement in prognosis for the last two decades, said Shire.

The CHMP reversed an earlier negative opinion on Proveca's Sialanar (glycopyrronium bromide) as a treatment for severe drooling in children and adolescents with neurological disorders, backing it under a paediatric use marketing authorisation (PUMA) which provides 10 years of market protection for off-patent drugs developed for specific applications in children.

This is only the third time that a PUMA has been recommended by the CHMP since the scheme came into being in 2007, said the panel.

Other positive recommendations were given for Aptalis' Truberzi (eluxadoline) as a treatment for irritable bowel syndrome with diarrhoea, along with two biosimilar versions of Sanofi's clot-busting drug Lovenox (enoxaparin) - Techdow's Inhixa and Pharmathen's Thorinane.

Article by
Phil Taylor

25th July 2016

From: Regulatory



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