It has cost him, but the Spanish pharmaceutical PharmaMar has once again hit the target. As happened almost 20 years ago with its famous medicine Yondelis, the Galician pharmaceutical company is about to succeed in taking it to the market
If in the first case with Yondelis -which is already used in 80 countries- the efficacy of the drug was demonstrated in a type of tissue and bone sarcoma and in ovarian cancer, on this occasion the new drug -called Zepsyre- has demonstrated its useful in a type of lung cancer for which there has been nothing new in the last 20 years.
The US has asked the firm to carry out a request for accelerated approval in order to shorten the deadlines
Today, the company announced that the US medical authorities have evaluated its new drug and are not only confident in its advantages, but have also asked the Spanish firm to carry out a request for accelerated approval in order to shorten the deadlines and have the treatment available in the shortest possible time.
The accelerated approval procedure of the FDA -the US Medicines Agency- allows the presentation of the registration dossier of the new medicine, for its evaluation, based on the results of the drugs in the second of the three phases of research for the treatment of serious diseases and that also cover a medical need, as in the case of Zepsyre from PharmaMar.
During the months of June or July 2020, the final approval of the new drug could be received.
After receiving this notification from the FDA, PharmaMar expects that the filing of the new drug registration application will take place during the fourth quarter of 2019 and, according to the company sources consulted, during the months of June or July 2020 it could receive final drug approval.
During the last American Congress of Oncology, held in Chicago last June, the president of PharmaMar, . “The results in the second phase of the three necessary have been very positive because our drug is aimed at the second line of treatment for a type of lung cancer in which there has been no novelty in recent years,” Fernández Sousa pointed out. .
Sales of 1,000 million
PharmaMar’s new drug could reach 60,000 patients with lung cancer, which would open up a market of about 2,000 million euros a year for the Spanish pharmaceutical company. According to several investment banks that follow the firm, the drug could reach 1,000 million euros in its highest annual sales peak.
In August 2018, PharmaMar’s treatment already received orphan drug designation for lung cancer in the US, which provides the pharmaceutical company with various benefits, including a seven-year period of market exclusivity if approved the drug, tax credits for clinical trials and an exemption from the application fees for marketing authorization of the drug before the health authorities.
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