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Teva's (TEVA) Migraine Drug Ajovy Receives FDA Approval
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Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced that the FDA has granted approval to its anti-calcitonin gene-related peptide (“CGRP”) drug, Ajovy (fremanezumab) injection, as a preventive treatment of migraine. The drug is the first and only anti-CGRP treatment, which is approved with monthly (225 mg) and quarterly (675 mg) dosing options.
Shares of Teva have gained 20.6% year to date against the industry’s increase of 4.1%.
The approval was backed by data from two pivotal studies evaluating Ajovy as monotherapy and in combination with oral preventive treatments in patients with disabling migraine. Data showed that the drug significantly reduced monthly migraine days over a 12-week period.
We remind investors that the approval comes three months after the original expected date in June. The delay was due to a warning letter from FDA to Teva’s partner Celltrion for a facility in South Korea, following an inspection of the fill/finish side of the facility. This facility manufactures active pharmaceutical ingredients (APIs) for fremanezumab.
Migraine has limited treatment options and anti-CGRP is a new treatment mechanism. However, Amgen (AMGN - Free Report) /Novartis’ (NVS - Free Report) Aimovig (erenumab) was approved and launched for prevention of migraine in the second quarter of 2018.
Teva has priced the monthly dose for Ajovy at $575, similar to Aimovig. The quarterly dose of Ajovy is priced at $1,725.
Apart from these two drugs, Eli Lilly’s (LLY - Free Report) anti-CGRP candidate, Emgality/galcanezumab, is also under review for a similar indication in the United States. A decision on Emgality is expected by the end of this month.
Demand for these drugs will depend on the commercial initiatives taken by the companies. It remains to be seen whether a single drug will lead the segment or will all drugs enjoy equal adoption. Per the press release, there are 36 million people in the United States affected with migraine. Preventive treatments are applicable for about 40% of these migraine patients, suggesting a multi-billion dollar market. An equal distribution of market share will also be beneficial for Teva.
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Teva's (TEVA) Migraine Drug Ajovy Receives FDA Approval
Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced that the FDA has granted approval to its anti-calcitonin gene-related peptide (“CGRP”) drug, Ajovy (fremanezumab) injection, as a preventive treatment of migraine. The drug is the first and only anti-CGRP treatment, which is approved with monthly (225 mg) and quarterly (675 mg) dosing options.
Shares of Teva have gained 20.6% year to date against the industry’s increase of 4.1%.
The approval was backed by data from two pivotal studies evaluating Ajovy as monotherapy and in combination with oral preventive treatments in patients with disabling migraine. Data showed that the drug significantly reduced monthly migraine days over a 12-week period.
We remind investors that the approval comes three months after the original expected date in June. The delay was due to a warning letter from FDA to Teva’s partner Celltrion for a facility in South Korea, following an inspection of the fill/finish side of the facility. This facility manufactures active pharmaceutical ingredients (APIs) for fremanezumab.
Migraine has limited treatment options and anti-CGRP is a new treatment mechanism. However, Amgen (AMGN - Free Report) /Novartis’ (NVS - Free Report) Aimovig (erenumab) was approved and launched for prevention of migraine in the second quarter of 2018.
Teva has priced the monthly dose for Ajovy at $575, similar to Aimovig. The quarterly dose of Ajovy is priced at $1,725.
Apart from these two drugs, Eli Lilly’s (LLY - Free Report) anti-CGRP candidate, Emgality/galcanezumab, is also under review for a similar indication in the United States. A decision on Emgality is expected by the end of this month.
Demand for these drugs will depend on the commercial initiatives taken by the companies. It remains to be seen whether a single drug will lead the segment or will all drugs enjoy equal adoption. Per the press release, there are 36 million people in the United States affected with migraine. Preventive treatments are applicable for about 40% of these migraine patients, suggesting a multi-billion dollar market. An equal distribution of market share will also be beneficial for Teva.
Teva Pharmaceutical Industries Ltd. Price
Teva Pharmaceutical Industries Ltd. Price | Teva Pharmaceutical Industries Ltd. Quote
Zacks Rank
Teva currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Much like petroleum 150 years ago, lithium battery power is set to shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge. With battery prices plummeting and charging stations set to multiply, revenues that were already at $31 billion in 2016 are expected to blast to over $67 billion by the end of 2022.
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