It was a busy week for the big drugmakers. The FDA granted approval to Lilly’s LLY calcitonin gene-related peptide ("CGRP") antibody, Emgality (galcanezumab) for migraine and Pfizer’s PFE Vizimpro (dacomitinib) for an advanced lung cancer indication. Novartis NVS announced plans to cut more than 2000 jobs in Switzerland and U.K. Meanwhile, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave positive opinions recommending marketing approval to several drugs this week.
Recap of the Week’s Most Important Stories
Pfizer’s New Lung Cancer Drug Gets FDA Approval: The FDA granted approval to Pfizer’s EGFR tyrosine kinase inhibitor dacomitinib for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with EGFR activating mutations. Other than dacomitinib, Pfizer has three other cancer medicines under FDA’s priority review –glasdegib, lorlatinib and talazoparib. Decisions on all these medicines are expected later this year.
Lilly’s New Migraine Treatment Receives FDA Nod: The FDA also granted approval to Lilly’s CGRP antibody, Emgality (galcanezumab – 120 mg injection) for the preventive treatment of migraine. This is the third CGRP antibody to get FDA approval this year. While Teva’s fremanezumab was approved earlier this month under the trade name of Ajovy, Amgen’s CGRP antibody, Aimovig/erenumab was approved and launched in the United States in the second quarter of 2018. Lilly has set the price for Emgality at $575 for once-monthly dosing or $6,900 annually. All the three drugs have an identical annual price tag of $6,900.
CHMP Gives Positive Opinion to Several Drugs: Lilly gained a positive CHMP opinion, recommending approval of Emgality for the prevention of migraine. The CHMP also gave a nod to AbbVie’s ABBV application looking for approval of its leukemia drug Venclexta in combination with Roche’s Rituxan for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (“CLL”) who have received at least one prior therapy. Regulatory applications seeking approval for the combination use in this broader patient population were approved in the United States in June.
Glaxo’s GSK filing looking for inclusion of data from the IMPACT study on the label of its single inhaler triple therapy, Trelegy Ellipta was also given a positive opinion by the CHMP. If approved, Telegy Ellipta can be prescribed as a maintenance treatment to a broader COPD patient population not adequately treated by a LABA/LAMA combination. Until now Trelegy Ellipta was approved as a maintenance treatment to treat those COPD patients who are not adequately treated by an ICS/LABA combination. A similar label update was approved by the FDA in April.
Bayer also won CHMP’s nod for its pipeline candidate BAY94-9027 for the treatment and prophylaxis of bleeding in previously treated patients with hemophilia A. BAY94-9027 was approved to be marketed by the trade name of Jivi by the FDA last month.
AstraZeneca AZN said that the CHMP has recommended inclusion of cardiovascular outcomes data from the EXSCEL study in the European label of its type-II diabetes medicine, Bydureon. For Novartis, the CHMP recommended approval of its multiple sclerosis drug Gilenya for the treatment of children and adolescents as well as its one-time gene therapy, Luxturna for the treatment of a rare inherited retinal disease.
The final decision by the European Union on these products is expected in the coming months
Novartis to Cut Jobs in U.K. and Switzerland: Novartis announced plans to cut some 1,700 jobs in Switzerland including 1,000 manufacturing positions and another 700 service and managerial jobs. The job cuts are expected to be executed over the next four years. Novartis also said it plans to exit its Grimsby manufacturing site by the end of 2020, which will affect jobs of 395 employees. The job cuts in U.K. and Switzerland are part of its previously announced initiative to transform its global manufacturing network and product portfolio.
Novartis also announced new data on pipeline candidate, brolucizumab (RTH258) from two phase III trials — HAWK and HARRIER. Data from the studies showed that brolucizumab 6 mg led to superior reduction in retinal fluid compared to Regeneron Eylea over four visits during weeks 36 to 48. Retinal fluid is a key marker of disease activity in neovascular age-related macular degeneration. Novartis plans to file regulatory application for approval of the candidate in December.
AstraZeneca’s Imfinzi Gets EU Approval for Lung Cancer: AstraZeneca’s PD-L1 inhibitor, Imfinzi was granted marketing approval in the EU by the European Commission for an early-stage lung cancer indication based on positive progression free survival data from the phase III PACIFIC study. Imfinzi is already approved for this indication in many countries including the United States.
AstraZeneca’s type II diabetes drug Farxiga led to statistical significant reduction in hospitalization for heart failure or CV death in a cardiovascular outcomes study. The phase III DECLARE- -TIMI 58 cardiovascular outcomes study was carried out in type-II diabetes who have multiple CV risk factors or established CV disease. The study compared the effect of Farxiga versus placebo in reducing the risk of MACE in such patients.
Roche Presents Data on Lung Cancer Candidate: Roche said that data from two pivotal studies showed that its cancer candidate entrectinib reduced tumors in patients with ROS1-positive non-small cell lung cancer (NSCLC), including in patients whose disease had spread to the central nervous system (CNS). An integrated analysis of phase II STARTRK-2 and phase I STARTRK-1 studies showed that entrectinib shrank tumors (objective response rate; ORR) in 77.4% of such patients and also demonstrated a durable response of more than two years in these patients. Roche plans to submit the data from these studies to the FDA and EMA.
FDA Accepts Allergan’s sNDA to Expand Vraylar Label: Allergan AGN said the FDA accepted its regulatory application looking to expand the label of its schizophrenia drug Vraylar (cariprazine) to include treatment of bipolar depression. Approval of the drug for the expanded indication will provide Allergan with access to a wider patient population base suffering bipolar issues. (Read More: Allergan Eyes Vraylar Label Expansion, FDA Accepts sNDA)
The NYSE ARCA Pharmaceutical Index rose 0.3% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
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All stocks were in the green this week except J&J and Merck. J&J declined the most (2.7%) while AstraZeneca recorded the highest gain of 5.3% in the last five trading sessions.
In the past six months, Lilly has been the biggest gainer (37.9%) while Bristol-Myers declined the most (2%).
(See the last pharma stock roundup here: AZN’s Leukemia Drug Wins FDA Nod, MRK’s Keytruda in Focus)
What's Next in the Pharma World?
Watch out for several pipeline and regulatory updates next week
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