New Delhi / Hyderabad: India’s drug regulator cancelled on Friday licences granted to 17 companies to produce anti-obesity drug rimonabant after Europe’s drug regulator recommended that member countries not allow the previously approved drug to be sold because it caused serious psychiatric side effects including suicidal tendencies.
The regulator had previously approved the sale of the generic version of the drug here by companies including Zydus Cadila, Sun Pharmaceutical Industries Ltd, Torrent Pharmaceuticals Ltd and Ranbaxy Laboratories Ltd.
Such approval, for drugs already patented and being sold elsewhere merely requires so-called bio-equivalence studies that seek to show that the drug’s generic version acts the same way the patented one does. The drug, created by Sanofi-Aventis SA isn’t patented in India.
Rimonabant was touted as the next blockbuster drug when it was launched by Sanofi Aventis in June 2006 in the European Union (EU) under the brand name Accomplia.
Interestingly, the drug wasn’t approved by the US drug regulator and wasn’t launched in that country. Apart from 18 countries in the EU, Sanofi Aventis was selling the drug in 14 countries including some in Latin America.
“Europe’s drug regulatory authority—European Medicines Agency (EMEA) suspended the manufacture of the drug in the UK and the European Union and the US food and drug administration did not approve it at all due to reports of severe (psychiatric) side effects. So, we are also suspending any further manufacture of the drug in India,” said drug controller general of India (DCGI) Surinder Singh. He added that the Central Drugs Standard Control Organization (CDSCO, the name of the organization headed by Singh) would not wait for any reported adverse reaction data from within India since “the country’s pharmacovigilance system is not very strong yet”.
All state licensing authorities have also been informed of the suspension of the drug in the market and rimonabant, under any brand name, should no longer be available for purchase. “We have a communication from the (drugs) regulator asking us to stop manufacturing rimonabant. We are complying with this communication with immediate effect,” said a Sun Pharma spokesperson. The company said it hadn’t received any reports of an adverse reaction to the drug it launched in 2007.
The drug was first launched in India by Torrent Pharma as Rimoslim in May 2007. Total sales from all 17 brands of rimonabant were worth Rs13 crore in the first nine months of this year, with Zydus Cadila’s Slimona selling the most (Rs4 crore), according to data from research firm ORG IMS.
Despite all the hype, rimonabant did not catch the fancy of many doctors in the country. “I used to prescribe versions of rimonabant to my patients for obesity and metabolic syndrome. But within a few months I started receiving complaints of severe depression, suicidal tendencies, irritability, lack of concentration, headache and reduction in social interaction from many patients,” recalls Dr Vipin Mishra, senior consultant, endocrinology, at Fortis Healthcare Ltd’s Fortis Hospital. Mishra added that he stopped prescribing the drug after the initial few months because “...it wasn’t very effective”.
EMEA’s recommendation was based on post-marketing data or details of post-launch feedback from the company and consumers. On 23 October, EMEA’s committee for medicinal products for human use (CHMP) concluded that the benefits of rimonabant no longer outweighed its risks and recommended the suspension of its marketing licence.
Following this, the UK suspended sales of the drug.
“Taking into account the concerns raised by some national and regional regulatory authorities, we decided to suspend the sales of rimonabant (Acomplia) in all the 32 countries,” Sanofi-Aventis spokesperson Jean-Marc Podvin said in a telephonic conversation with Mint.
The company also suspended so-called phase III human clinical trials of the drug in several countries, including India, that would have allowed the company to apply for marketing approval for Acomplia. “All rimonabant related clinical trials, currently going on in about 50 (additional) countries, have been suspended. Further, we have stopped development related activities related to this drug,” Podvin said. He declined details of how much the company had spent on these trails in India and other markets.
Subsequently, Pfizer Inc. announced it was terminating the phase III development of a similar molecule CP-945,598. “While confident in the safety of the compound, we believe that this is the appropriate decision based on all available information regarding this class of agents, as well as recent discussions with regulatory authorities,” said Martin Mackay, president, Pfizer Global research and development, in a press release.
In the first nine months of the calendar year 2008, rimonabant contributed $81 million (Rs401 crore) to the $26,201 million revenue of Sanofi-Aventis. “We expect the impact of rimonabant sales suspension on company’s whole year profits to be in the range of $50 million,” Podvin said.