This week was ruled by FDA and EU approvals for new cancer therapies as well as line extensions of cancer drugs. These included EU approvals for Novartis’ NVS CAR-T Kymriah and Tafinlar plus Mekinist combination for a third indication and FDA approval for AbbVie ABBV/J&J’s JNJ Imbruvica in combination with Roche’s RHHBY Rituxan for a rare cancer.
The FDA also approved Merck’s MRK two new HIV medicines containing its investigational medicine, doravirine. Meanwhile, Pfizer PFE presented late-stage study data on a rare disease candidate and announced termination of two studies on a candidate being developed for the treatment of Duchenne muscular dystrophy (DMD).
Recap of the Week’s Most Important Stories
FDA Approves Merck’s HIV Medicines: Merck announced that the FDA approved two new HIV drugs containing its investigational medicine, doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of patients who have not received any antiretroviral therapies before.
While doravirine approved as a once-daily single tablet in combination with other antiretroviral agents will be marketed by the trade name of Pifeltro, a once-daily fixed-dose combination regimen containing doravirine, lamivudine and tenofovir disoproxil fumarate will be sold as Delstrigo. The FDA’s decision came almost two months in advance.
Pfizer Presents Data on Rare-Disease Candidate, Terminates DMD Candidate: Pfizer presented primary data from a phase III study, ATTR-ACT, evaluating its pipeline candidate tafamidis in patients with wild-type or variant (hereditary) transthyretin amyloid cardiomyopathy (ATTR-CM), a rare illness associated with progressive heart failure. Data from the study showed that treatment with tafamidis led to a significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations — the primary endpoint — compared with placebo at 30 months. Treatment with tafamidis led to a 30% reduction in the risk of mortality and 32% reduction in the rate of cardiovascular-related hospitalization compared to placebo. The data were presented at the European Society of Cardiology congress.
Pfizer also announced the termination of two studies evaluating its pipeline candidate domagrozumab (PF-06252616) for the treatment of DMD, a severe type of muscular dystrophy, due to lack of a “significant treatment effect”. It clarified that the studies were not discontinued for safety issues and it will evaluate the total data set to see if the candidate has any prospect in the treatment of muscular diseases. Meanwhile, Pfizer is also evaluating a gene therapy, PF-06939926, for DMD.
Cancer Approvals in EU for Novartis: Novartis’ chimeric antigen receptor T cell (CAR-T) therapy, Kymriah was approved by the European Commission for relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) and r/r diffuse large B-cell lymphoma (DLBCL). Kymriah is already approved in the United States for this indication. Kymriah sales came in at $28 million in the first half of 2018.
Novartis’ BRAF/MEK inhibitor combination, Tafinlar plus Mekinist also gained EU approvalf or adjuvant treatment of BRAF V600 mutation-positive melanoma. This was the third indication for which the cancer combination is now approved in the EU. In the United States, the Tafinlar + Mekinist combination was approved for the same indication in April.
Also, Novartis’ eye care division, Alcon, announced that it is voluntarily recalling its CyPass Micro-Stent for surgical glaucoma from the global markets. The withdrawal was based on five-year data from the COMPASS-XT long-term safety study, which showed cell loss in patients. Novartis said the decision is not expected to hurt the planned spin-off of Alcon in 2019.
AbbVie’s Imbruvica+Rituxan Combo Gets FDA Nod for Rare Cancer: AbbVie and J&J’s cancer drug Imbruvica was approved by the FDA to be used in combination with Roche’s Rituxan for the treatment of Waldenström's macroglobulinemia (WM), a rare form of Non-Hodgkin’s lymphoma. With the latest approval, Imbruvica is approved for nine indications across six different cancer types. (Read more: AbbVie's Imbruvica Combo Gets FDA Nod for Rare Lymphoma)
J&J/Bayer’s Xarelto Fails in Label Expansion Studies: J&J and Bayer’s blood thinner, Xarelto failed to show statistical significant benefits in two studies — MARINER and COMMANDER HF — which were being conducted to expand the eligible patient population for Xarelto. In the MARINER study, Xarelto did not reduce venous thromboembolism (VTE), or blood clots, and VTE-related death in acute medically ill patients after discharge from hospital. The COMMANDER HF study was conducted to see if Xarelto was effective in reducing the risk of heart attack, stroke and death in sick patients with significant coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF) who experienced a recent episode of acute decompensated heart failure (ADHF).
In this study too, Xarelto did not impact overall mortality outcomes compared to standard of care. The results were presented at the European Society of Cardiology congress in Munich and also published in The New England Journal of Medicine. (Read more: Bayer's Blood Thinner Xarelto Fails in Line Extension Studies).
EU Nod for label Expansion of AstraZeneca and Glaxo’s Products: The European Commission approved AstraZeneca’s Bydureon BCise injectable suspension, a new formulation of its diabetes medicine Bydureon in an improved once-weekly, single-dose pre-filled BCise device. This formulation was approved in the United States in October last year.
The regulatory agency also gave marketing approval for Glaxo’s GSK Nucala as an add-on treatment for severe refractory eosinophilic asthma in the pediatric patient population (aged six up to 17 years) in Europe.
The NYSE ARCA Pharmaceutical Index rose 0.2% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions:
It was a mixed performance this week. While Pfizer declined the most (1.7%), AstraZeneca recorded the highest gain of 2.1% in the last five trading sessions.
In the past six months, Lilly remains the biggest gainer (37.9%) while Bristol-Myers declined the most (7.6%).
(See the last pharma stock roundup here: Pharma Stock Roundup: FDA Blow for AGN, Label Expansion Nod for MRK, BMY Cancer Drugs)
What's Next in the Pharma World?
Watch out for several pipeline and regulatory updates next week
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