This week, J&J JNJ gained FDA approval for its antidepressant, Spravato (esketamine). It was the first approval for a depression drug in decades. Lilly LLY said that it will soon launch a cheaper version of its popular insulin, Humalog amid increasing pressure to lower drug costs. The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (EMA) meanwhile recommended marketing approval for several drugs.
Recap of the Week’s Most Important Headlines
J&J’s Spravato Gets FDA Approval with a Boxed Warning: J&J gets FDA nod for its new nasal spray, Spravato (esketamine) for treatment-resistant depression, a difficult-to-treat mental disease. With the approval, Spravato, which works differently from all other currently available antidepressants, became the first new medicine in 30 years to treat depression.
While most antidepressants take a couple of weeks or months to show effects, Spravato works in hours. To avoid misuse and abuse of the drug, Spravato has been approved with a boxed warning on its label regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behavior in pediatric patients and young adults.
CHMP Gives Positive Opinion to Several Drugs: Pfizer PFE gained positive CHMP opinion, which recommended conditional marketing approval of lorlatinib for ALK-positive previously treated non-small cell lung cancer (“NSCLC). Lorlatinib will be marketed by the trade name of Lorviqua in the EU. In the United States, it gained FDA approval in the name of Lorbrena in November 2018.
The CHMP also gave a nod to AstraZeneca AZN and Merck’s MRK application looking for approval of cancer drug Lynparza in a new patient population — germline BRCA-mutated HER2-negative advanced breast cancer previously treated with chemotherapy. Lynparza is already approved in the United States for this indication. Merck also gained CHMP nod for a six-week dosing schedule of Keytruda across all current monotherapy indications.
AbbVie’s ABBV filing looking for approval of risankizumab, its investigational interleukin-23 (IL-23) inhibitor, for the treatment of moderate-to-severe plaque psoriasis, was also given a positive opinion by the CHMP. Risankizumab is also under review in the United States, where a decision from the FDA is expected in the first half of the year.
Glaxo received a positive CHMP opinion for intravenous zanamivir for the treatment of complicated influenza. An inhaled version of zanamivir is marketed as Relenza by Glaxo while the intravenous version, if approved, will be called Dectova. The CHMP also recommended approval of Sanofi/Regeneron’s Dupixent for the second indication, asthma and Sanofi/Lexicon’s Zynquista (sotagliflozin) for type I diabetes.
The final decision by the European Union on these products is expected in the coming months.
Lilly to Launch Cheaper Insulin: Lilly announced plans to launch a cheaper version of its popular insulin, Humalog. The list price of the authorized generic version, to be called Insulin Lispro and containing an identical molecule as Humalog, will be 50% lower than the current list price of Humalog. Insulin Lispro will be available in vial and pen (KwikPen) options. Lilly is working to make the insulin available as quickly as possible.
The FDA granted priority review to Lilly’s filing looking for approval of label expansion of its CGRP antibody, Emgality (galcanezumab) for preventive treatment of episodic cluster headache. Lilly gained FDA approval for Emgality for the preventive treatment of migraine in adults in late September last year.
Roche’s Tecentriq plus Avastin Combo Gets EU Nod in First-Line Lung Cancer: Roche RHHBY gained approval in the EU for Tecentriq in combination with Avastin and chemotherapy for the first-line treatment of metastatic NSCLC based on results from the Phase III IMpower150 study. However, in EGFR mutant or ALK-positive metastatic NSCLC patients, the combination is approved for use only after appropriate targeted therapy. In the U.S. Tecentriq plus Avastin and chemotherapy was approved for the initial treatment of metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations in December last year.
The FDA accepted Roche’s supplemental new drug application (sNDA) looking for approval of its antiviral medicine Xofluza in people at high risk of complications from flu. The FDA’s decision is expected on Nov 4. There are no approved therapies to treat the high-risk influenza patient population. Xofluza was approved by the FDA in October 2018 for the treatment of acute, uncomplicated influenza in people 12 years of age or older.
Roche filed a sBLA looking for approval of a combination of Roche/AbbVie’s Venclexta plus Roche’s Gazyva (obinutuzumab) as a first-line therapy with a fixed duration of treatment in patients with chronic lymphocytic leukemia with co-existing medical conditions. Moreover, the combination was granted a breakthrough therapy designation (BTD) by the FDA, the fifth one for Venclexta.
Allergan’s Depression Candidate Fails: Allergan’s three acute pivotal studies on depression candidate, rapastinel, failed to meet their primary endpoint. The studies were evaluating rapastinel, its NMDA receptor modulator, as an adjunctive treatment of major depressive disorder (MDD) compared to placebo, both in combination with antidepressant therapy (ADT).
The FDA accepted Allergan’s supplemental biologics license applications (sBLAs) looking to expand the label of the blockbuster product Botox for pediatric patients with upper and lower limb spasticity. While a decision on upper limb spasticity indication is expected in the second quarter of this year with the FDA granting priority review to the sBLA, the same for pediatric lower limb spasticity indication is expected in the fourth quarter. Botox is approved for both the indications in adults.
The NYSE ARCA Pharmaceutical Index declined 0.7% 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 in the last five trading sessions. While J&J recorded the highest gain of 1.2%, Pfizer declined the most (4.5%).
In the past six months, Lilly remains the biggest gainer (18.7%) while Bristol-Myers declined the most (15.4%).
(See the last pharma stock roundup here: Roche to Buy ONCE, Lawmakers Grill CEOs Over High Drug Prices)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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