PARIS, Dec 22 (APM) - Thursday’s Les Echos said Johnson & Johnson’s Darzalex’s is still not officially marketed in France in multiple myeloma as a monotherapy despite having received an approval in May 2016.
The newspaper reported the drug has demonstrated its efficacy in this indication during trials, but still has not been given an official reimbursement price.
Les Echos noted Darzalex is already available through a temporary reimbursement scheme, ATU (Temporary authorisation of use) at 6,456 euros per month, compared to 5,052 euros a month in Germany.
It also underlined Darzalex cannot receive an ATU for another indication, in combination with chemotherapy, as the regulation cannot grant another ATU for a product that has already received it for a first indication.
Les Echos criticised this situation, adding new positive clinical data have been published from a Phase III trial in combination for new diagnosed patients and a 16 months follow-up.
"Even though there is little distance to say if the product gives positive results on the survival rate, Janssen decided to submit a dossier for a use in first line treatment," continued the newspaper.
It also noted this drug is strategic for the company, as analysts credit it with potential peak sales of $8.5 billion.
The paper did not mention an important element of the case. French HTA authority’s commission in charge of evaluating medicines in the view of their reimbursement, Commission de la transparence (CT), gave its decision on the product early December (APMHE 55888
The authority judged its efficacy compared to existing treatments was minor in combination therapy and had no additional therapeutic value as monotherapy.
The reimbursement price of a compound is decided by another committee, CEPS (Comité économique des produits de santé) on the basis of CT’s recommandation.
Levothyrox: more than 500 complaints filed against Merck KGaA
Monday’s 20 Minutes (p12) reported that more than 500 complaints have been filed in the courts against Merck KGaA in the Levothyrox scandal.
The newspaper also said in a separate piece on the same day the company is facing a new round in Toulouse in another procedure where patients are asking the court to force the company to market the former formulation of its product.
The newspaper said this trial gathers plaintiffs who could not join a first similar trial in which the company was orderd to import the former formulation and supply it to French patients. (APMHE 55911
In a report on Tuesday L’Humanité (p10) reported a French patients association, Vivre sans thyroïde, filed another complaint against the company and French drug watchdog ANSM, 'in order to obtain answers about the new formulation".
The article said the association wants to gain access to all administrative documents related to the approval of new formulation, and to pharmacovigilance data.
French medical research seeks to reassure on new mandatory vaccines
Tuesday’s La Croix (p8) reported French medical research institute Inserm has issued an official statement to reassure French about the safety of vaccines, as the 11 new mandatory jabs will come into force on Jan 1.
J&J recalls lots of constipation treatment
Wednesday’s Le Parisien (brief p14) briefly noted J&J has recalled lots of its constipation treatment Lansoyl after fragments of glass were found in this product in Belgium.
Weekly newspaper Le Point (website) added the recall was announced by French medicines agency ANSM and targets three lots of the product.
The report noted this problem seems to be isolated and the measure has been taken as a precaution.
J&J fined for blocking generics
On Thursday, Le Figaro (p25) reported French Competition authority has ordered Johnson & Johnson to pay a 25 million euros fine for having tried to block the use of generics of its painkiller Durogesic. (APMHE 56171
Anniversary of law authorising abortion pill
Monday’s Le Parisien (brief p17) reminded the legalisation of abortion pill was voted on Dec 19, 1967.