Yahoo Finance AstraZeneca Gets CHMP Nod for Forxiga/Fasenra Expanded Label
AstraZeneca Plc AZN announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for label expansion of its diabetes drug Forxiga and respiratory drug Fasenra.
The CHMP has recommended a change to the to the European label of Forxiga (dapagliflozin) to include cardiovascular (CV) outcomes data from the phase III DECLARE-TIMI 58 study.
The DECLARE-TIMI 58 study evaluated the cardiovascular (CV) and renal effects of Forxiga (dapagliflozin) in adults with type II diabetes compared to placebo.
Data from the study showed Forxiga produced a statistically significant drop in the rate of hospitalisation for heart failure of cardiovascular death compared to a placebo which was one of the two primary efficacy endpoints. There were fewer major adverse CV events observed with Forxiga for the other primary efficacy endpoint, however this did not reach statistical significance.
Forxiga was approved for type I diabetes indication in Europe in March 2019 and is under review in the United States for the same indication with a decision expected in the second half of 2019. Forxiga is known by the name of Farxiga in United States. AstraZeneca’s shares have risen 11.2% so far this year compared with the industry’s increase of 6.3%.
Further, the CHMP issued a positive opinion recommending approval of a a self-administration option for Fasenra (benralizumab) and
and the new delivery method - a pre-filled, single-use auto-injector (the Fasenra pen).
to the medicine’s product information in the European Union. The positive opinion for self-administration and the Fasenra pen is supported by data from the phase III GREGALE and GRECO studies, and the phase I AMES study, respectively. The safety and tolerability of Fasenra in these studies were consistent with the known profile of the medicine.
The company expects a regulatory decision by the FDA on self-administration and the new pre-filled, single-use auto-injector device in the second half of 2019.
Fasenra is AstraZeneca’s first respiratory biologic and is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the United States, Europe, Japan and other countries. GlaxoSmithKline’s GSK Nucala and Teva Pharmaceutical Industries' TEVA Cinqair are presently marketed for the same indication
Successful label expansion of Foriga and Fasenra in additional indications should drive sales of these drugs further.
AstraZeneca PLC Price
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Zacks Rank and Stock to Consider
AstraZeneca currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the large-cap pharmaceutical sector include Novartis AG NVS carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Novartis’ earnings per share estimates increased from $4.98 to $5.01 for 2019 and from $5.48 to $5.56 for 2020 over the past 60 days. Share price of the company has increased 24.5% year to date.
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