Furthermore, the Committee has advised patients to take antibiotics when using Zydelig for 2-6 months in order to avoid any type of infections, such as Pneumocystis jirovecii pneumonia. The PRAC’s recommendations will be forwarded to the EMA’s Committee for Medicinal Products for Human Use (CHMP) for the final verdict.
Earlier in March, the cancer drug faced a disaster, as serious side effects were reported in the clinical trials, along with multiple deaths, in 6 undergoing studies in newly-diagnosed patients suffering from leukemia and lymphoma. Due to this, the company has stopped all programs using Zydelig as a first-line therapy. However, it is working on the treatment’s label expansion in combination with other oncology drugs.
Zydelig is an oral phosphoinositide 3-kinase (PI3K) delta inhibitor, which plays a vital role in the activation and proliferation of B-cells. In the US, the Food and Drug Administration (FDA) has already approved it—in combination with Roche Holding’s Rituxan—to manage and treat chronic lymphocytic leukemia. In 2014, it was given approval in the EU. The drug is expected to generate sales worth $800 million by fiscal year 2020 (FY20).
The hold status on the clinical trials has put a dent in Zydelig’s label expansion program, because the first-line therapy always receives a major chunk of patients. Moreover, the ones enrolled in the clinical trials remain on the specified drug for a longer duration.
In a note to investors, Leerink Partners analyst Geoffrey Porges mentioned: “These decisions by Gilead and the regulators effectively mean that Zydelig is dead in the water, since it can no longer be used in the preferred combinations, and in the most common patient populations. […] It also finally resolves the Zydelig vs. Imbruvica debate—clearly in favor of Imbruvica.”
To overcome this problem, Gilead announced that it has obtained approval for Epclusa—its hepatitis C drug—in the EU. It was earlier approved by the FDA in June 2015. The drug is the first one to receive the green signal for the treatment of all Hepatitis C Virus (HCV) 1-6 genotypes, and has been authorized for use without Ribavarin in genotype 2 and 3 HCV.
With the approval, the company will provide full coverage to HCV patients. CEO John Milligan commented: “The burden of hepatitis C across Europe is substantial, and growing rapidly with approximately 15 million people chronically infected. The European approval of SOF/VEL reflects our continued focus to bring a cure to all infected patients across the region, and we look forward to working with physicians, healthcare providers, and governments to make it available as quickly as possible."
Its noteworthy competitors include Johnson & Johnson. Another peer is AbbVie Inc.’s Imbruvica (ibrutinib), which was launched in March 2016, has captured the therapeutic market of leukemia and lymphoma, and is expected to touch $12 billion in revenues.
The drug maker now intends to look for alternate revenue generation sources. It is working on ways to enter into the lucrative oncology market. While the company’s drug pipeline has multiple cancer molecules, they are in initial phases, and will take time to be approved.
According to The Street, chief scientific officer Norbert Bischofberger is optimistic on the company’s oncology product portfolio. The company has plans to work on multiple types of novel platforms for the development of immunoncology drugs.