Press review

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Spain enforces EMA restrictions on Sanofi’s MS drug Lemtrada

MADRID, 18 Apr (APM) - Use of Sanofi’s multiple sclerosis drug Lemtrada (alemtuzumab) is being restricted in Spain following the decision by the European Medicines Agency (EMA) to start an investigation on its safety, newspaper ABC reported on Tuesday.
Reports of severe adverse reactions to Lemtrada - including liver damage caused by autoimmune hepatitis, hemophagocytic lymphohistiocytosis, myocardial infarction, stroke and lung haemorrhage - will be analysed by the EMA’s drug safety committee PRAC, which has started a review of the drug, ABC noted. (APMHE 62664)
Lemtrada is a monoclonal antibody approved in 2013 to treat adults with relapsing-remitting MS and active disease confirmed by magnetic resonance images (MRI), the newspaper added.
Until the review offers more information about its safety, the drug will only be started in adults with highly active drug resistant MS, previously treated with at least two disease-modifying drugs (DMDs), or patients in which any other medicines are not an option, ABC noted.
Close monitoring has been recommended by Spanish regulator AEMPS for patients being treated with Lemtrada, the newspaper said.

Experts group welcomes new HTA committee

The Spanish Association of Health Economics (AES) has offered a positive opinion on the creation of the newly created committee which will help guide the country's decisions on the pricing and reimbursement of drugs, financial El Economista reported on Wednesday. (APMHE 62389)
According to a statement posted on AES’ website, the creation of the committee shows the government’s commitment with improving HTA in terms of transparency, El Economista reported.
AES representatives met with senior ministry officials earlier this week, where they emphasised that transparency in the evaluation of new drugs will improve efficiency and generate confidence among the public, the financial added.

Janssen’s neuroscience head marks Spravato a game-changing depression drug

On Tuesday, daily El País carried an interview with Janssen's head of neuroscience, Husseini Manji, who discussed the development and expected benefits of antidepressant nasal spray Spravato (esketamine).
El País quoted Víctor Pérez, director of neuropsychiatry at Hospital del Mar in Barcelona, as saying: “Depression is a colossal health issue. For many years, clinicians did not have any new drugs to treat this disease, but this changed in March with the approval of esketamine”. (APMHE 62146)
The drug’s price in the U.S. will range from $590 to $885 per session, with an estimated monthly cost of more than $4,700, El País reported.
Manji told the newspaper that the new drug will contribute to the treatment an important unmet medical need. “In the U.S. suicide is the third cause of death, only surpassed by two types of cancer”, he said.
He added that one of the most interesting features of Sprivo is that its benefits remain for weeks after one session and highlighted it is a fast-acting medicine.

Sprout's failed attempt to abolish restrictions on female libido pill

The U.S. Food and Drug Administration (FDA) has said that women taking Sprout Pharmaceuticals’ female libido pill Addyi (flibanserin) do not need to completely avoid alcohol, but the firm’s attempts to have all boxed warnings removed has failed, financial Cinco Días reported on Tuesday. (APMHE 62645)
Instead of completely removing the boxed warning, the FDA ordered Sprout to change the drug's label to reflect that patients should stop drinking two hours before taking Addyi at bedtime or to skip the dose that evening.
Cinco Días quoted an FDA statement as saying it had made the order since it was not possible to reach an agreement with the company, which was continuing to request removal of the boxed warning and contraindication about alcohol completely from the product labelling.
According to the financial publication, restrictions on alcohol consumption when taking the so-called ‘female Viagra’ are one of the reasons the drug is not selling as much as the firm expected.
Addyi is very different from Viagra. Instead of an instant effect, it requires a sustained and expensive treatment of one daily dose for at least eight weeks to show benefits, Cinco Días added.

Spain’s pharma ready to fight work instability

Pharma operating in Spain had implemented moves to fight work instability before the government recently passed new regulation on the matter, medical journal Redacción Médica reported on Tuesday.
The journal quoted sources from branded pharma lobby Farmaindustria as saying: “Branded pharma will of course meet the standards of the new regulation”.
But pharma had already implemented moves regarding female workforce and hiring young talent, the journal added.
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