GlaxoSmithKline’s Relvar Ellipta gains EU marketing authorization ahead of Advair generics.
By Rajan Sharma, Senior Analyst
22 November 2013
I joined Datamonitor Healthcare in late in 2013 after completing a Masters in Pharmacology from the University of Oxford...
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On 18 November 2013, GlaxoSmithKline and Theravance’s Relvar Ellipta (fluticasone furoate/vilanterol) gained European marketing authorization for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Relvar’s launch will be a key aspect of GlaxoSmithKline’s strategy to minimize the potential impact of generic alternatives to Advair (fluticasone/salmeterol), the company’s blockbuster inhaler.
Relvar, marketed as Breo in the US, is a once-daily inhaled corticosteroid/long-acting beta 2 agonist (ICS/LABA). The decision to approve Relvar was made following a total of 26 clinical studies involving 7,783 COPD and 9,326 asthma patients. The drug will be administered using GlaxoSmithKline’s new Ellipta inhaler, with a low dose (92/22mcg) approved for both indications, and an additional high dose (184/22mcg) approved for asthma. Already approved by the US Food and Drug Administration (FDA) for the treatment of COPD, and in Japan for the treatment of asthma, the drug is seen as a follow-on to GlaxoSmithKline’s twice-daily ICS/LABA, Advair. GlaxoSmithKline and Theravance are reviewing their strategy for an FDA asthma filing and Datamonitor Healthcare believes a US launch for asthma will be essential to maintaining GlaxoSmithKline’s strong position in the respiratory market. With the product currently in a Phase III trial in the US, Datamonitor Healthcare forecasts a 2015 launch for asthma in that market.
Relvar’s EU launch is expected in Q1 2014, in advance of competitors such as Novartis’s QMF149, which Datamonitor Healthcare expects will be the second once-daily ICS/LABA to market in 2017. Importantly, Relvar will also launch before generic competitors to GlaxoSmithKline’s Advair reach the market. These factors are expected to have a significant bearing on Relvar’s success in what is becoming an increasingly competitive market.
Key opinion leaders interviewed by Datamonitor Healthcare have remained unsure of the true advantage of Relvar’s once-daily dosing profile. Therefore, Datamonitor Healthcare expects strong marketing from GlaxoSmithKline in order to encourage swift patient switching from Advair as it attempts to safeguard its respiratory portfolio.
The biggest market shake-up is expected to come from the wave of much anticipated fixed-dose LABA/long-acting anticholinergic (LAMA) combination inhalers entering the COPD market. With its own LABA/LAMA, Anoro (umeclidinium/vilanterol), expected to launch in 2014, this is a challenge that GlaxoSmithKline appears to be prepared for. Anoro’s launch will ensure the company has a presence in both the ICS/LABA and LABA/LAMA markets, putting it in a strong position to mitigate expected Advair erosion.
The combined asthma and COPD markets are forecast to be worth $27bn in the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) by 2021, and Datamonitor Healthcare expects GlaxoSmithKline to maintain its stronghold. Combined Relvar sales in both indications in the US, Japan, and five major EU markets are forecast to peak at $3.9bn in 2021. With another $961m added by Anoro, the combined sales of both drugs are forecast to be $4.9bn in the same year.
Posted in Respiratory. Tagged to Advair, asthma, Chronic obstructive pulmonary disease, COPD, fluticasone furoate/vilanterol, fluticasone/salmeterol, GlaxoSmithKline, GSK, inhalor, Relvar Ellipta, Theravance