Thyroid cancer, TB resistance drugs top EMA approvals
pharmafile | December 23, 2013 | News story | Sales and Marketing | EMA, TB, thyroid
The European Medicines Agency has shown the green light to a new treatment for thyroid cancer and one for drug resistant tuberculosis.
The Agency’s drug safety and efficacy arm the CHMP has recommended that Exelixis’ Cometriq (cabozantinib) be given EU approval for the treatment of patients with progressive metastatic medullary thyroid carcinoma (MTC).
Cometriq is a small molecule that inhibits the activity of multiple tyrosine kinases, including RET, MET, and VEGF receptor.
The CHMP’s positive decision came after a Phase III study in October 2012 showed the drug improved median progression-free survival in by 11.2 months, versus just four months in the placebo arm.
The drug was approved by the FDA in late 2012 and marketed in the US from January this year, and made just under $5 million in the third quarter.
It will now compete with AstraZeneca’s Caprelsa (vandetanib), which was approved in Europe in early 2012 for the treatment of aggressive and symptomatic medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Caprelsa is not expected to be a blockbuster given its limited approval and small sub population of patients, and is forecast to bring in just $112 million a year by 2016, according to analysts.
TB resistance
Meanwhile, Janssen’s Sirturo (bedaquiline) has gained a conditional EU marketing approval as part of a combination therapy for pulmonary multidrug-resistant tuberculosis (TB) in adult patients when another treatment cannot be used because of resistance, or tolerability.
Multidrug-resistant TB is a growing concern around the world as antibiotic medicines start to lose their efficacy against the disease.
The official diagnosis of a patient resistant to TB medicines is when they are resistant to at least isoniazid and rifampicin, which are two major anti-TB medicines used in standard treatment.
Around 450,000 cases of multidrug-resistant tuberculosis occur globally every year – equating to around 5% of the world’s annual burden of the disease.
Multidrug-resistant TB is linked to a high death rate and poses a significant public health threat, as individuals infected with drug-resistant strains are unable to receive adequate treatment and can potentially spread their infection.
Sirturo is the first of a new class of medicines against mycobacteria, and the CHMP considered that the drug could contribute in responding to the high unmet medical need for new treatment options for pulmonary multidrug-resistant tuberculosis.
It recommended granting conditional marketing authorisation because, although the data supplied by Janssen shows that the medicine’s benefits outweigh its risks, the data are not yet comprehensive.
Therefore additional studies on the use of Sirturo should be conducted, the CHMP said in a statement.
Sirturo is the third positive opinion recently granted by the CHMP for a medicine to be used in the treatment of multidrug-resistant tuberculosis, after the November 2013 recommendations for Deltyba (also for a conditional approval) and Para-aminosalicylic acid Lucane.
Both Sirturo and Cometriq will now be sent to the European Commission for a formal approval, which usually takes around three months.
Ben Adams
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