EMA expands nods for BMS, Eli Lilly, Novartis drugs and backs Biohaven, VBI, Myovant therapies for first time

The European drug regulator is adding new indications for several drugs in boons to Novartis, Bristol Myers Squibb and Eli Lilly. It's also backing first-time approvals for Biohaven, VBI Vaccines and Myovant Sciences.

In an important update for Eli Lilly, drug reviewers at the European Medicines Agency have recommended the use of CDK4/6 inhibitor Verzenios—known as Verzenio in the U.S.—in combination with endocrine therapy for postsurgery adjuvant treatment of HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.

Verzenio snagged that first-in-class approval in the U.S. in October, gaining an edge over Pfizer’s market-leading Ibrance. The U.S. adjuvant nod led to “an inflection in both new and total prescriptions” for Verzenio, Eli Lilly chief financial officer Anat Ashkenazi said during the company’s four-quarter earnings call earlier this month.

As Lilly’s oncology chief Jake Van Naarden noted, changing 20 years of practice and challenging a significant CDK4/6 lead by Ibrance is a tall task. Many physicians have only prescribed Ibrance in the past and are not familiar with adding a CDK4/6 drug in the adjuvant setting, he said.

What’s more, the U.S. indication requires a patient to score at least 20% on the Ki-67 marker—which indicates tumor cell proliferation and growth—to be eligible for Verzenio in the adjuvant setting. That requirement is also new to physicians.

RELATED: Eli Lilly's Verzenio snags first-in-class FDA approval for early breast cancer. But limited label poses a challenge

Meanwhile, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is also supporting the addition of three new indications to the label of Bristol Myers Squibb’s PD-1 inhibitor Opdivo.

They include Opdivo’s use alongside either chemotherapy or Yervoy for newly diagnosed esophageal squamous cell carcinoma with tumor cell PD-L1 expression of at least 1%. Opdivo monotherapy also won backing for the adjuvant treatment of PD-L1-positive muscle-invasive bladder cancer that are at high risk of recurrence after surgery.

In addition, Novartis’ Beovu is on track to expand into diabetic macular edema in EU, even though safety concerns will continue to haunt the anti-VEGF drug.

RELATED: Buckle up AbbVie, Amgen: Biohaven's oral CGRP drug is gaining traction in migraine, doctors' survey shows

As for new drugs, Biohaven’s Pfizer-partnered Vydura—sold as Nurtec ODT in the U.S.—won a positive opinion from CHMP for preventative and acute treatment of migraine. The oral CGRP is enjoying rapid growth in the U.S., pressuring the market potential of injectables from the likes of Amgen and Lilly.

Elsewhere, VBI Vaccines’ trivalent hepatitis B shot PreHevbri—known as PreHevbrio, got a CHMP greenlight, with an official European Commission approval likely to follow in weeks. The CHMP backing came right after the U.S. CDC’s Advisory Committee on Immunization Practices recommended the vaccine for adult prevention of hepatitis B following an FDA nod in November.

The CHMP also backed approvals for Immunocore’s Kimmtrak in uveal melanoma, Idorsia’s insomnia drug Quviviq, Vifor Pharma’s Kapruvia for treating moderate-to-severe pruritus associated with chronic kidney diseases and Myovant Sciences’ androgen deprivation therapy Orgovyx in hormone-sensitive prostate cancer. Myovant is currently partnered with Pfizer on Orgovyx in the U.S., and the biotech has said it would sign with a partner in Europe upon an official nod there.